Trial Outcomes & Findings for Engaging Men From Blue-collar Industries in Weight Loss (NCT NCT05386238)
NCT ID: NCT05386238
Last Updated: 2025-03-18
Results Overview
Acceptability of the intervention will be reported as participants' satisfaction with the program rated on a 4-point scale. "How satisfied are you overall with the weight management program you received from the Study?"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-18
Participant Flow
Participants were recruited between September 28, 2022, and March 30, 2023. Recruitment was closed before our planned sample size was recruited to complete the study within the funding period
All consented participants were randomized into the study. 63 who completed the initial screening were excluded due to not meeting eligibility criteria, 9 were unable to be contacted, and 17 did not complete the study enrollment procedures.
Participant milestones
| Measure |
Tailored Treatment
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Tailored Treatment
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Engaging Men From Blue-collar Industries in Weight Loss
Baseline characteristics by cohort
| Measure |
Tailored Treatment
n=14 Participants
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=14 Participants
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
n=99 Participants
|
44 years
n=107 Participants
|
44 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
BMI (kg/m2)
|
31.6 kg/m2
n=99 Participants
|
33.4 kg/m2
n=107 Participants
|
31.8 kg/m2
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAcceptability of the intervention will be reported as participants' satisfaction with the program rated on a 4-point scale. "How satisfied are you overall with the weight management program you received from the Study?"
Outcome measures
| Measure |
Tailored Treatment
n=12 Participants
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=11 Participants
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Endorsement
The recruitment message included a quote from a prior participant indicating satisfaction with the program and the standard recruitment message.
|
Combined
Combined the standard recruitment message with the enhanced trust and endorsement messages.
|
|---|---|---|---|---|
|
Participant Satisfaction With the Intervention
Very Dissatisfied
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Participant Satisfaction With the Intervention
Dissatisfied
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Participant Satisfaction With the Intervention
Somewhat Satisfied
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Participant Satisfaction With the Intervention
Very Satisfied
|
7 Participants
|
8 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 1000 postcards of each message type were sent to men in the recruitment area. A subset of postcards were returned undelivered and were removed from the analysis.
The proportion of participants who enroll in the study by recruitment message type.
Outcome measures
| Measure |
Tailored Treatment
n=906 Participants
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=942 Participants
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Endorsement
n=915 Participants
The recruitment message included a quote from a prior participant indicating satisfaction with the program and the standard recruitment message.
|
Combined
n=931 Participants
Combined the standard recruitment message with the enhanced trust and endorsement messages.
|
|---|---|---|---|---|
|
Recruitment Response
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsProportion of participants who complete the final follow up assessment
Outcome measures
| Measure |
Tailored Treatment
n=14 Participants
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=14 Participants
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Endorsement
The recruitment message included a quote from a prior participant indicating satisfaction with the program and the standard recruitment message.
|
Combined
Combined the standard recruitment message with the enhanced trust and endorsement messages.
|
|---|---|---|---|---|
|
Retention Rates for Each Intervention Group
|
11 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: 1000 postcards of each message type were sent to men in the recruitment area. A subset of postcards were returned undelivered and were removed from the analysis.
Number of visits to study websites
Outcome measures
| Measure |
Tailored Treatment
n=906 Participants
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=942 Participants
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Endorsement
n=915 Participants
The recruitment message included a quote from a prior participant indicating satisfaction with the program and the standard recruitment message.
|
Combined
n=931 Participants
Combined the standard recruitment message with the enhanced trust and endorsement messages.
|
|---|---|---|---|---|
|
Recruitment Reach
|
34 Participants
|
14 Participants
|
17 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsProportion of participants who achieve a weight loss \>5% of initial weight
Outcome measures
| Measure |
Tailored Treatment
n=14 Participants
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=14 Participants
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Endorsement
The recruitment message included a quote from a prior participant indicating satisfaction with the program and the standard recruitment message.
|
Combined
Combined the standard recruitment message with the enhanced trust and endorsement messages.
|
|---|---|---|---|---|
|
Clinically Significant Weight Loss
|
4 Participants
|
4 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsSemi-structured interviews to evaluate participants perceptions of program
Outcome measures
Outcome data not reported
Adverse Events
Tailored Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tailored Treatment
n=14 participants at risk
6-months of group-based behavioral weight loss treatment tailored to men working in blue-collar occupations.
Tailored behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts or videos tailored to men working in blue-collar occupations. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
Standard of Care Treatment
n=14 participants at risk
6-months of group-based behavioral weight loss treatment following the Diabetes Prevention Program Group Lifestyle balance.
Standard behavioral weight loss program: 16 internet-delivered, group sessions over 6 months supported by digital handouts. The intervention will focus on changes to eating, physical activity, and self-monitoring.
|
|---|---|---|
|
General disorders
Emergency room visit
|
0.00%
0/14 • Collected at 3 and 6 months assessments systematically and as reported by participants during intervention visits
|
14.3%
2/14 • Collected at 3 and 6 months assessments systematically and as reported by participants during intervention visits
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/14 • Collected at 3 and 6 months assessments systematically and as reported by participants during intervention visits
|
7.1%
1/14 • Collected at 3 and 6 months assessments systematically and as reported by participants during intervention visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place