Trial Outcomes & Findings for Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss Intervention (NCT NCT05295849)

NCT ID: NCT05295849

Last Updated: 2024-11-26

Results Overview

Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-11-26

Participant Flow

Participant milestones

Participant milestones
Measure
Habit App
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proof-of-Concept Study of an Integrated Mobile and Social Network Weight Loss Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
41.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
Race (NIH/OMB)
White
14 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
20 Participants
n=5 Participants
Body Mass Index
32.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to use the temptation tracker on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Uses of the Temptation Tracker
9.5 uses of this mobile app feature
Standard Deviation 6.3

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Slips Reported
4.8 slips reported
Standard Deviation 3.5

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to report whether a temptation led to a slip or if they resisted on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Temptations Resisted
4.7 temptations resisted
Standard Deviation 6.1

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to plan their exercise in advance on weeks 3 and 4 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Exercises Planned
14.0 exercises planned
Standard Deviation 10.5

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Total Problems Solved
2.9 problems solved
Standard Deviation 2

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Diet Problems Solved
1.9 diet problems solved
Standard Deviation 1.5

PRIMARY outcome

Timeframe: 2 weeks

Participants were asked to use the app problem solver on weeks 5 and 6 of the intervention. Uses were extracted from the app's backend server.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Mean Number of Exercise Problems Solved
1.0 exercise problems solved
Standard Deviation 0.5

PRIMARY outcome

Timeframe: 6 weeks

Participants will rate how much they agree with the statement "I would continue to use the Habit app after the study if given the chance" on 5-point Likert scales.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance
11 Participants

PRIMARY outcome

Timeframe: 6 weeks

Participants will rate how much they agree with the following statement "I would recommend the Habit app to a friend who is trying to lose weight" on a 5-point Likert scale.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend
10 Participants

PRIMARY outcome

Timeframe: 6 weeks

Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (temptation/slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Number of Participants Rating the Temptation and Slip Tracker as Time-consuming
14 Participants

PRIMARY outcome

Timeframe: 6 weeks

Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Number of Participants Rating the Problem Solver as Time-consuming
11 Participants

PRIMARY outcome

Timeframe: 6 weeks

Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, etc) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Number of Participants Rating the Exercise Planner as Time-consuming
11 Participants

PRIMARY outcome

Timeframe: 6 weeks

Using Grytics, we will retrieve objective engagement data from the Facebook group, including the date and content of all posts, replies, reactions, and poll votes. We will calculate the total number of posts, replies, reactions, and poll votes per participant.

Outcome measures

Outcome measures
Measure
Habit App
n=20 Participants
Habit Mobile App Building Habits Together Online Weight Loss 6-Week Usability Trial: The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.
Median Total Engagements in the Facebook Group
62 total engagements
Interval 32.0 to 128.0

Adverse Events

Habit App

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

Sherry Pagoto, PhD

University of Connecticut

Phone: 860-486-5917

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place