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

NCT05295849 | Completed Results DMC

• 2 other identifiers: H20-00601R34HL145439-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this 6 week single-arm pilot is to evaluate the feasibility of the Habit app plus Facebook group intervention in 20 adults with obesity. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app.

Conditions

Obesity

Keywords

obesity; lifestyle intervention; mobile app

Outcome Measures

Primary Outcomes (13)

• Mean Number of Uses of the Temptation Tracker

  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.

  2 weeks

• Mean Number of Slips Reported

  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.

  2 weeks

• Mean Number of Temptations Resisted

  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.

  2 weeks

• Mean Number of Exercises Planned

  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.

  2 weeks

• Mean Number of Total Problems Solved

  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.

  2 weeks

• Mean Number of Diet Problems Solved

  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.

  2 weeks

• Mean Number of Exercise Problems Solved

  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.

  2 weeks

• Number of Participants Saying They Agree or Strongly Agree They Would Continue to Use the Habit App if Given the Chance

  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.

  6 weeks

• Number of Participants Saying They Agree or Strongly Agree That They Would Recommend the Habit App to a Friend

  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.

  6 weeks

• Number of Participants Rating the Temptation and Slip Tracker as Time-consuming

  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.

  6 weeks

• Number of Participants Rating the Problem Solver as Time-consuming

  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.

  6 weeks

• Number of Participants Rating the Exercise Planner as Time-consuming

  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.

  6 weeks

• Median Total Engagements in the Facebook Group

  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.

  6 weeks

Study Arms (1)

Habit App

EXPERIMENTAL

Habit Mobile App

Behavioral: Building Habits Together Online Weight Loss 6-Week Usability Trial

Interventions

Building Habits Together Online Weight Loss 6-Week Usability Trial BEHAVIORAL

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.

Habit App

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• BMI 30-45 kg/m2
• has wifi connectivity at home (for wifi scale)
• logs into Facebook at least 5 days per week over the past 2 weeks, and has posted/replied at least once a week in the past 2 weeks
• able to participate in the study in English.

You may not qualify if:

• Pregnant/lactating or plans to become pregnant during study period
• bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression
• had bariatric surgery or plans to have surgery during the study
• currently taking medication affecting weight
• has lost ≥10% of weight in past year
• is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving
• chronic pain that interferes with the ability to exercise
• Type 1 or 2 Diabetes
• unable to make dietary changes or increase physical activity
• unable to walk ¼ mile unaided without stopping
• currently smokes or vapes nicotine
• does not live in the United States
• had major surgery in past 6 months
• hospitalized for psychiatric reasons in past 12 months
• has concerns about being audiotaped during the focus groups

Sponsors & Collaborators

• University of Connecticut: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Worcester Polytechnic Institute: collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sherry Pagoto, PhD
• Organization: University of Connecticut

sherry.pagoto@uconn.edu

860-486-5917

Study Officials

• Sherry Pagoto, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: single-arm usability pilot

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: March 25, 2022
• Study Start: July 18, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately after publication
• Access Criteria: After the publication of outcome data, data will be made available to individuals who have IRB approval.

Locations

US (1)