Trial Outcomes & Findings for Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention (NCT NCT05715242)
NCT ID: NCT05715242
Last Updated: 2025-05-16
Results Overview
average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
baseline to 10 weeks
Results posted on
2025-05-16
Participant Flow
Participants were enrolled into the Ignite study during a 7-week period between December 5, 2023 and January 23, 2024. The trial was fully remote, with recruitment of adults across the United States.
After informed consent was provided, participants were asked to complete a baseline survey, sync their e-scale and activity tracker with the Fitbit app, and submit their baseline weight. Once those tasks were completed, participants were randomized into 1 of 16 conditions.
Participant milestones
| Measure |
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
Completed 4-Week Assessment
|
2
|
2
|
1
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
2
|
2
|
1
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
Baseline characteristics by cohort
| Measure |
Condition 1
n=2 Participants
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 2
n=2 Participants
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 3
n=2 Participants
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 4
n=2 Participants
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 5
n=2 Participants
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 6
n=2 Participants
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 7
n=2 Participants
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 8
n=2 Participants
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 9
n=2 Participants
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 10
n=2 Participants
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 11
n=2 Participants
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 12
n=2 Participants
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Condition 13
n=2 Participants
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Condition 14
n=2 Participants
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Condition 15
n=2 Participants
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Condition 16
n=2 Participants
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
47.0 years
STANDARD_DEVIATION 18.4 • n=107 Participants
|
30.5 years
STANDARD_DEVIATION 0.7 • n=206 Participants
|
33.5 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 17.0 • n=31 Participants
|
69.5 years
STANDARD_DEVIATION 0.7 • n=30 Participants
|
52.0 years
STANDARD_DEVIATION 18.4 • n=3 Participants
|
48.5 years
STANDARD_DEVIATION 0.7 • n=6 Participants
|
44.0 years
STANDARD_DEVIATION 11.3 • n=114 Participants
|
54.0 years
STANDARD_DEVIATION 18.4
|
53.5 years
STANDARD_DEVIATION 14.8 • n=19 Participants
|
52.0 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 27.6 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 17.7 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 0.7 • n=3 Participants
|
42.5 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 13.3 • n=2 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
24 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=2 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
21 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
27 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
|
Weight
|
167.5 lbs.
STANDARD_DEVIATION 4.6 • n=99 Participants
|
184.7 lbs.
STANDARD_DEVIATION 22.6 • n=107 Participants
|
182.3 lbs.
STANDARD_DEVIATION 4.2 • n=206 Participants
|
199.2 lbs.
STANDARD_DEVIATION 32.0 • n=7 Participants
|
187.0 lbs.
STANDARD_DEVIATION 16.4 • n=31 Participants
|
204.1 lbs.
STANDARD_DEVIATION 59.5 • n=30 Participants
|
171.9 lbs.
STANDARD_DEVIATION 17.7 • n=3 Participants
|
178.8 lbs.
STANDARD_DEVIATION 28.0 • n=6 Participants
|
162.4 lbs.
STANDARD_DEVIATION 0.6 • n=114 Participants
|
216.1 lbs.
STANDARD_DEVIATION 5.2
|
193.0 lbs.
STANDARD_DEVIATION 31.2 • n=19 Participants
|
192.2 lbs.
STANDARD_DEVIATION 25.2 • n=4 Participants
|
180.2 lbs.
STANDARD_DEVIATION 29.1 • n=7 Participants
|
169.6 lbs.
STANDARD_DEVIATION 0.6 • n=7 Participants
|
201.7 lbs.
STANDARD_DEVIATION 22.6 • n=3 Participants
|
232.5 lbs.
STANDARD_DEVIATION 35.4 • n=4 Participants
|
188.9 lbs.
STANDARD_DEVIATION 26.2 • n=2 Participants
|
PRIMARY outcome
Timeframe: baseline to 10 weeksaverage percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
Outcome measures
| Measure |
All Participants
n=32 Participants
all randomized participants
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Engagement in Self-monitoring Body Weight
|
89 % of intervention days
Interval 69.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline to 10 weeksaverage percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility
Outcome measures
| Measure |
All Participants
n=16 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Engagement in Self-monitoring Steps
|
100 % of intervention days
Interval 90.0 to 100.0
|
100 % of intervention days
Interval 98.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline to 10 weeksaverage percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility
Outcome measures
| Measure |
All Participants
n=16 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Engagement in Self-monitoring Dietary Intake
|
54 % of intervention days
Interval 20.0 to 93.0
|
79 % of intervention days
Interval 41.0 to 92.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Among completers of 10-week survey
1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability
Outcome measures
| Measure |
All Participants
n=30 Participants
all randomized participants
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
|
29 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 weeksthe proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility
Outcome measures
| Measure |
All Participants
n=16 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
n=16 Participants
Participants receive an easier daily step goal.
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
n=16 Participants
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
n=16 Participants
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
n=16 Participants
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
n=16 Participants
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Retention Rate
|
14 Participants
|
16 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: baseline; 10 weeksthe proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
Outcome measures
| Measure |
All Participants
n=32 Participants
all randomized participants
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Survey Completion Rate
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to 10 weeksPopulation: among participants with ≥1 day of self-monitoring calories
average percentage of days in the 10-week intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility
Outcome measures
| Measure |
All Participants
n=13 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Goal Attainment of Calorie Goal
|
43 % of intervention days
Interval 14.0 to 59.0
|
29 % of intervention days
Interval 13.0 to 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to 10 weeksPopulation: among participants with ≥1 day of self-monitoring steps
average percentage of days in the 10-week intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility
Outcome measures
| Measure |
All Participants
n=15 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Goal Attainment of Step Goal
|
34 % of intervention days
Interval 24.0 to 45.0
|
32 % of intervention days
Interval 16.0 to 60.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to 10 weeksPopulation: among participants with ≥ 1 day of self-monitoring eating window
average percentage of days in the 10-week intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility
Outcome measures
| Measure |
All Participants
n=16 Participants
all randomized participants
|
Step Goal: Harder
n=15 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Goal Attainment of Eating Window Goal
|
67 % of intervention days
Interval 43.0 to 93.0
|
81 % of intervention days
Interval 68.0 to 93.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to 10 weeksPopulation: among participants with ≥1 day of self-monitoring Red Zone Foods
average percentage of days (out of days instructed to track Red Zone Foods) in the 10-week intervention of meeting the daily Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility
Outcome measures
| Measure |
All Participants
n=15 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
Participants receive an easier daily step goal.
|
Step Goal: Harder
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
(Feasibility) Goal Attainment of Red Zone Food Goal
|
46 % of intervention days
Interval 8.0 to 96.0
|
54 % of intervention days
Interval 35.0 to 94.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to 10 weekspercentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale
Outcome measures
| Measure |
All Participants
n=16 Participants
all randomized participants
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Step Goal: Easier
n=16 Participants
Participants receive an easier daily step goal.
|
Step Goal: Harder
n=16 Participants
Participants receive a harder daily step goal.
|
Eating Window Goal: Easier
n=16 Participants
Participants receive an easier daily eating window goal.
|
Eating Window Goal: Harder
n=16 Participants
Participants receive a harder daily eating window goal.
|
Red Zone Food Goal: Easier
n=16 Participants
Participants receive an easier daily Red Zone Food goal.
|
Red Zone Food Goal: Harder
n=16 Participants
Participants receive a harder daily Red Zone Food goal.
|
|---|---|---|---|---|---|---|---|---|
|
Weight
|
-2.72 % weight change
Standard Deviation 3.63
|
-4.86 % weight change
Standard Deviation 3.30
|
-3.45 % weight change
Standard Deviation 3.81
|
-4.13 % weight change
Standard Deviation 3.42
|
-4.19 % weight change
Standard Deviation 2.79
|
-3.39 % weight change
Standard Deviation 4.28
|
-3.98 % weight change
Standard Deviation 2.94
|
-3.60 % weight change
Standard Deviation 4.21
|
Adverse Events
Condition 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 11
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 13
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 14
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 15
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Condition 16
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michele L. Patel, PhD
Stanford University School of Medicine
Phone: 650-549-7047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place