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Completed

NCT Number: NCT05295849

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

The purpose of this single-arm pilot is to evaluate the feasibility of the intervention in 20 adults with obesity. We define feasibility as use of the mobile app features (dietary self-monitoring, slip tracker, and problem sharing/solving), retention, engagement (overall, problem solving), acceptability, and burden. This study will give us information that we can use to modify the intervention and our procedures before the larger pilot study. We will enroll 20 adults with obesity to participate in the 6-week pilot. Eligible participants will receive a link to complete surveys, mailed a wifi scale, and asked to provide staff with login information for the scale so weight can be recorded during assessments. They will then have a 60-minute call with a counselor to 1) download and receive training on program technology (MyFitnessPal, Habit app, and Fitbit scale) and 2) be entered into the Facebook group. 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. Every Monday in the group, participants will be given one diet and one exercise goal for the week and every Sunday they will be asked to share their progress on those goals. Every Friday they will participate in a "weigh in" thread in the group. In addition to the group, for the first two weeks, participants will be asked to use MyFitnessPal; for the second two weeks, they will be asked to use the Temptation/Slip Tracker and Exercise Planner; and for the final two weeks they will be asked to use the Problem Solver. We will ask each participant to share at least one diet or exercise problem with the group over the 6 weeks and to participate in each other's problem solving posts. Participants may attend optional weekly breakout sessions where weight loss related problems will be discussed. On the final day of the intervention, a post will go up in the group asking for a volunteer who used the app enough to brainstorm how to improve it to participate in a team meeting to discuss how to improve the program. If more than one participant volunteers, one will be randomly selected to participate. After the 6-week intervention, participants will complete the weight loss problem solving skills survey, provide a final weight, and complete individual phone interviews to discuss their experience. We will convene a team meeting with the investigators, interventionists, and a participant to discuss the results and any modifications that should be made to the program before progressing to the pilot study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 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.

Exclusion criteria

  • 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
  • does not have or not willing to create Fitbit account for study
  • unable to access smartphone at home and at work
  • does not have FB
  • has done a study with this PI before
  • has concerns about being in FB group with faculty/students of same university in which they work/attend
  • does not have smartphone
  • smartphone type/version not meeting app requirements
  • prisoner
  • unable to provide consent
  • does not complete onboarding steps for the study

Treatment and study plan

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.

Primary outcomes

  1. Mean Number of Uses of the Temptation Tracker

    Time frame: 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.

  2. Mean Number of Slips Reported

    Time frame: 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.

  3. Mean Number of Temptations Resisted

    Time frame: 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.

  4. Mean Number of Exercises Planned

    Time frame: 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.

  5. Mean Number of Total Problems Solved

    Time frame: 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.

  6. Mean Number of Diet Problems Solved

    Time frame: 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.

  7. Mean Number of Exercise Problems Solved

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  11. Number of Participants Rating the Problem Solver as Time-consuming

    Time frame: 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.

  12. Number of Participants Rating the Exercise Planner as Time-consuming

    Time frame: 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.

  13. Median Total Engagements in the Facebook Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Worcester Polytechnic Institute

Registry information

Official study title

Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention

Acronym: BHT-OWL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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