Trial Outcomes & Findings for Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes (NCT NCT06127251)
NCT ID: NCT06127251
Last Updated: 2026-07-22
Results Overview
Participants who visited the PATH platform at least twice weekly.
COMPLETED
NA
54 participants
12 weeks
2026-07-22
Participant Flow
Participants were recruited from Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began April 11, 2024, and all follow-up was completed by May 18, 2025.
Participant milestones
| Measure |
PATH Intervention
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes
Baseline characteristics by cohort
| Measure |
PATH Intervention
n=27 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=27 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 10.9 • n=9 Participants
|
49.3 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
49.5 years
STANDARD_DEVIATION 11.7 • n=267 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
50 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=9 Participants
|
27 participants
n=27 Participants
|
54 participants
n=267 Participants
|
|
College Educated
|
20 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
|
Income meets financial needs
|
23 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
|
Body Mass Index (BMI)
|
40.5 Kg/m^2
STANDARD_DEVIATION 9.9 • n=9 Participants
|
39.8 Kg/m^2
STANDARD_DEVIATION 7.9 • n=27 Participants
|
40.2 Kg/m^2
STANDARD_DEVIATION 8.9 • n=267 Participants
|
|
Weight
|
240.4 lbs
STANDARD_DEVIATION 52.3 • n=9 Participants
|
250.1 lbs
STANDARD_DEVIATION 56.4 • n=27 Participants
|
245.3 lbs
STANDARD_DEVIATION 54.1 • n=267 Participants
|
|
Body Fat Percentage
|
45.3 percentage of fat
STANDARD_DEVIATION 6.1 • n=9 Participants
|
44.5 percentage of fat
STANDARD_DEVIATION 7.6 • n=27 Participants
|
44.9 percentage of fat
STANDARD_DEVIATION 6.9 • n=267 Participants
|
|
Waist Circumference
|
48.8 inches
STANDARD_DEVIATION 7.8 • n=9 Participants
|
46.9 inches
STANDARD_DEVIATION 6.1 • n=27 Participants
|
47.9 inches
STANDARD_DEVIATION 7.00 • n=267 Participants
|
|
Blood Pressure (BP)
Systolic BP
|
133.0 mmHg
STANDARD_DEVIATION 18.3 • n=9 Participants
|
135.6 mmHg
STANDARD_DEVIATION 20.6 • n=27 Participants
|
134.3 mmHg
STANDARD_DEVIATION 19.3 • n=267 Participants
|
|
Blood Pressure (BP)
Diastolic BP
|
82.2 mmHg
STANDARD_DEVIATION 12.1 • n=9 Participants
|
84.0 mmHg
STANDARD_DEVIATION 11.3 • n=27 Participants
|
83.1 mmHg
STANDARD_DEVIATION 11.7 • n=267 Participants
|
|
Self-reported Moderate-to-Vigorous Physical Activity (MVPA)
|
61.9 minutes/week
STANDARD_DEVIATION 49.2 • n=9 Participants
|
39.4 minutes/week
STANDARD_DEVIATION 40.9 • n=27 Participants
|
50.7 minutes/week
STANDARD_DEVIATION 46.2 • n=267 Participants
|
PRIMARY outcome
Timeframe: 4 months after screening procedures startNumber of participants enrolled within 4 months after the study opened to enrollment.
Outcome measures
| Measure |
PATH Intervention
n=27 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=27 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Participants Enrolled Within 4 Months of Study Opening
|
27 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants (Retention rate) retained in each group at 12 weeks after enrollment
Outcome measures
| Measure |
PATH Intervention
n=27 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=27 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Number of Participants Retained in Each Group
|
26 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This outcome applies to the PATH intervention arm only.
The System Usability Scale (SUS) is an industry-standard, 10-item questionnaire used to evaluate the perceived usability of a product, system, or service. It provides a quick, reliable, and quantifiable measure of ease of use and user satisfaction. Users rate their level of agreement or disagreement with 10 statements using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Responses are converted and summed according to standard SUS scoring and transformed to a total score ranging from 0 to 100. The average score is about 68. A score above 68 is considered above average/good; a score below 68 is below average. Acceptability Ranges: Scores above 70 are typically considered "Acceptable," while scores below 50 usually indicate a system with poorer usability that needs to be redesigned.
Outcome measures
| Measure |
PATH Intervention
n=27 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
The System Usability Scale
|
79.6 score on a scale
Standard Deviation 13.3
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This outcome applies to the PATH intervention arm only. The analyzed population includes participants with data considered valid and suitable for analysis.
Participant satisfaction was assessed using an end-of-study user experience survey. Participants rated navigation ease (extremely easy/very easy) and overall satisfaction with the content and messaging. Navigation ease (extremely/very easy) Cultural appropriateness (very/somewhat appropriate) Workout access (extremely/very easy) Text reminders helpful (extremely/very helpful)
Outcome measures
| Measure |
PATH Intervention
n=21 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Participants' Satisfaction of Protocol Procedures (Acceptability)
Navigation ease (extremely/very easy)
|
14 Participants
|
—
|
|
Participants' Satisfaction of Protocol Procedures (Acceptability)
Cultural appropriateness (very/somewhat appropriate)
|
18 Participants
|
—
|
|
Participants' Satisfaction of Protocol Procedures (Acceptability)
Workout access (extremely/very easy)
|
15 Participants
|
—
|
|
Participants' Satisfaction of Protocol Procedures (Acceptability)
Text reminders helpful (extremely/very helpful)
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This outcome applies to the PATH intervention arm only. The analyzed population includes participants with data considered valid and suitable for analysis.
Participants who visited the PATH platform at least twice weekly.
Outcome measures
| Measure |
PATH Intervention
n=20 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Participants' Engagement
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Dried blood spot (DBS) samples for adiponectin and leptin were collected from participants per protocol. Due to shipping delays (2-4 months between collection and receipt), the laboratory did not process all samples for cytokine analysis in the multiplex panel. Adiponectin was planned to be conducted separately, but due to evidence of sample degradation from shipping delays, no further analysis is planned, as documented degradation would render unreliable values from these samples.
Adiponectin is a hormone released by adipose tissue and other body tissues, which assists with insulin sensitivity and reduces inflammation. Normal ranges vary depending on sex and BMI and in general lower levels are associated with health conditions of obesity, Type 2 diabetes, and atherosclerosis. Adiponectin and leptin will be collected via dry blood spot kits. A significant increase in adiponectin and decline in leptin, and T2D risk score will indicate improved adipocytokine and cardiometabolic risk profile and vice versa.
Outcome measures
| Measure |
PATH Intervention
n=24 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=21 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Adiponectin and Leptin
Leptin (Baseline)
|
909 pg/mL
Interval 253.0 to
|
1,102 pg/mL
Interval 364.0 to
|
|
Adiponectin and Leptin
Leptin (12 weeks)
|
1,359 pg/mL
Interval 603.0 to
|
864 pg/mL
Interval 369.0 to
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Samples were collected via DBS kits mailed by participants. Shipping delays were documented: samples collected during the study period (May-November 2024) were not received by the Biofluid Lab until 2-4 months later. A small number of samples were not analyzable for MCP-1.
MCP-1 is one of the key chemokines that regulate the migration and infiltration of monocytes/macrophages. MCP-1 will be collected via dry blood spot kits. A significant decline in MCP-1 will indicate improved adipocytokine and cardiometabolic risk profile and vice versa.
Outcome measures
| Measure |
PATH Intervention
n=24 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=22 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Monocyte Chemoattractant Protein-1 (MCP-1)
MCP-1 (Baseline)
|
27.8 pg/mL
Interval 5.7 to 41.0
|
23.9 pg/mL
Interval 8.8 to 37.0
|
|
Monocyte Chemoattractant Protein-1 (MCP-1)
MCP-1 (12 weeks)
|
26.1 pg/mL
Interval 7.6 to 42.4
|
29.4 pg/mL
Interval 9.2 to 42.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Samples were collected via mailed dried blood spot (DBS) kits without controlled transit time or temperature conditions. Some IL-1β and CRP samples were not analyzable, and several IL-6 and TNF-α values were below the assay detection limit.
Proinflammatory cytokines: tumor necrosis factor Alpha (TNF-α), Interleukin-1 beta (IL1β), and Interleukin-6 (IL6), and CRP will be collected via dry blood spot kits. A significant decline in TNF-α, IL1β, and IL6 will indicate improved adipocytokine and cardiometabolic risk profile, and vice versa.
Outcome measures
| Measure |
PATH Intervention
n=24 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=22 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Proinflammatory Cytokines
IL-1β (Baseline)
|
4.74 pg/mL
Interval 2.14 to 9.25
|
5.42 pg/mL
Interval 1.75 to 10.6
|
|
Proinflammatory Cytokines
IL-1β (12 weeks)
|
7.40 pg/mL
Interval 3.23 to 12.4
|
9.33 pg/mL
Interval 2.55 to 19.7
|
|
Proinflammatory Cytokines
IL-6 (Baseline)
|
0.10 pg/mL
Interval 0.09 to 0.15
|
0.13 pg/mL
Interval 0.06 to 0.16
|
|
Proinflammatory Cytokines
IL-6 (12 weeks)
|
0.21 pg/mL
Interval 0.13 to 0.28
|
0.16 pg/mL
Interval 0.08 to 0.19
|
|
Proinflammatory Cytokines
TNF-alpha (Baseline)
|
0.25 pg/mL
Interval 0.15 to 0.33
|
0.27 pg/mL
Interval 0.17 to 0.49
|
|
Proinflammatory Cytokines
TNF-alpha (12 weeks)
|
0.30 pg/mL
Interval 0.24 to 0.37
|
0.36 pg/mL
Interval 0.22 to 0.37
|
|
Proinflammatory Cytokines
CRP (Baseline)
|
218,006 pg/mL
|
276,209 pg/mL
|
|
Proinflammatory Cytokines
CRP (12 weeks)
|
255,839 pg/mL
|
267,276 pg/mL
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Insulin was collected via dried blood spot (DBS) kits mailed by participants. Shipping delays of 2-4 months were documented for samples collected during May-November 2024. Due to potential pre-analytical degradation and assay performance issues on a subset of samples, n=21 per arm had analyzable insulin data.
Collected via Dried Blood Spot (DBS) kits
Outcome measures
| Measure |
PATH Intervention
n=21 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=21 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Insulin Levels
12 weeks
|
0.50 uIU/ml
Interval 0.22 to 0.99
|
0.41 uIU/ml
Interval 0.24 to 1.11
|
|
Insulin Levels
Baseline
|
0.20 uIU/ml
Interval 0.12 to 0.35
|
0.43 uIU/ml
Interval 0.15 to 0.68
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe calculation of the American Diabetes Association (ADA) T2D risk score includes covariates such as age, sex, family history of diabetes, history of high blood pressure (BP), body mass index, and PA regimen (total score of 0-11). Scores ≥5 should be formally screened for diabetes per ADA guidelines.
Outcome measures
| Measure |
PATH Intervention
n=27 Participants
Insufficiently active adults with obesity will be assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
PA tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
Control Group
n=27 Participants
Insufficiently active adults with obesity will be assigned to the attention control group.
Control Group: Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Physical activity tracker: Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
|
|---|---|---|
|
Type 2 Diabetes (T2D) Risk Score
12 weeks
|
4.88 score on a scale
Standard Deviation 1.48
|
4.96 score on a scale
Standard Deviation 1.34
|
|
Type 2 Diabetes (T2D) Risk Score
Baseline
|
5.44 score on a scale
Standard Deviation 1.36
|
5.26 score on a scale
Standard Deviation 1.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksEXSE Scale assesses an individual's beliefs in their ability to continue exercising on a three-time-per-week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). The total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksExercise Self-regulation involves skills for planning, organizing, and managing exercise activities. will be measured by the Exercise Goal-Setting Scale (EGS) and the Exercise Planning and Scheduling Scale (EPS). Participants will rate 10 EGS items and 10 EPS items on a 5-point scale ranging from 1 (does not describe) to 5 (describes completely). Higher levels of self-regulatory skills, such as goal-setting, self-monitoring, planning, and problem-solving, may result in higher levels of PA.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksThe Physical Activity Enjoyment Scale is an 18-item scale that assesses enjoyment of physical activity by asking participants to rate "how do you feel at the moment about the physical activity you have been doing" using a 7- point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksSSQ has two-part answer questions. It asks to list up to 9 people who provide support that meets the criteria stated in the question. The support persons are listed by initials and relationship to the participant. Participants then rate their satisfaction (1 - very dissatisfied to 6 - very satisfied) with the support of each person stated in the first part. The support score (SSQN) is calculated by the average of the individual scores across the 27 items. A high score indicates more optimism about life than a low score. Low SSQ scores have a higher prevalence of negative life events and illness. Add the total number of people for all 27 items. (Max. is 243). Divide by 27 for the average item score=SSQ Number Score (SSQN) Add the total satisfaction scores for all 27 items. (Max is 162). Divide by 27 for the average item score=SSQ Satisfaction score (SSQS) Average the above for the total number of family members - this results in the SSQ family score
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 weeksThe Outcome Expectations for Exercise Scale (OEE) contains 9 statements rated by participants using a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree". The OEE was made primarily to study older adults with low expectations of the effects of exercise.
Outcome measures
Outcome data not reported
Adverse Events
PATH Intervention
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place