ObesityNCT06154213
Building Habits Together Online Weight Loss Program
A study testing Building Habits Together and Getting Healthy Together in people with Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Building Habits Together and Getting Healthy Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Body mass index (BMI) 27-45 kg/m2
- Wi-Fi connectivity at home
- Logs into Facebook at least 5 days per week over the past 2 weeks
- Has posted/replied on Facebook at least once a week in the past 2 weeks
- Able to participate in the study in English
- Interested in losing weight
Who cannot join
- Under the age of 18 and over the age of 65
- BMI under 27 or over 45 at screening; then under 27 at the point of the first weight on scale
- Does not have Wi-Fi connectivity at home
- Does not have a Facebook account
- Does not log into Facebook at least 5 days per week over the past 2 weeks
- Did not post/reply on Facebook once a week over the past 2 weeks
Show all 36Show fewer
- Not able to participate in the study in English
- Does not live in the United States
- Not interested in losing weight
- Pregnant/lactating or plans to become pregnant during study period
- Reports having bipolar disorder, substance abuse, psychosis, an eating disorder, or severe depression
- Had bariatric surgery or plans to have surgery during the study
- Currently taking medication affecting weight
- Has lost ≥5% of weight in past 3 months
- 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
- Has Type 1 Diabetes
- Has Type 2 Diabetes
- Unable to make dietary changes or increase physical activity
- Unable to walk ¼ mile unaided without stopping
- Currently smokes or vapes nicotine
- No phone connectivity at home and work
- Has a digestive disorder/condition that precludes dietary changes
- Meets criteria for severe depression on the Patient Health Questionnaire (PHQ)-8 (score of >19)
- Does not currently own a smartphone
- Smartphone type and/or version not meeting app requirements
- Participated in previous weight loss studies under the PI
- Unable to attend the orientation webinar
- If University of Connecticut (UConn) employee/student has concerns about being in a Facebook group with other UConn faculty, staff, and students
- Had major surgery in past 6 months and have not been cleared by their doctor to resume physical activity and diet changes
- Plans to have major surgery in the next 6-months
- Has an implanted cardiac defibrillator or pacemaker
- Did not complete screening and on-board processes of study (screening survey, webinar, e-consent, baseline survey, app set-up, scale set-up, etc.)
- Not willing to be audiotaped for focus groups
- Prisoner; or
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Building Habits Together Online Weight Loss Program: Pilot Trial
The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app.
Read the detailed description
The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults with overweight or obesity will receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app will be asked to record their weight daily, monitor their dietary temptations, plan their exercise, and solve diet and exercise related problems. The temptation tracker helps users identify triggers and track when and why those triggers lead to dietary lapses. The exercise planner allows users to plan their exercise for the week and track whether they completed or missed the exercise and why they missed it. The Habit app provides insights to users about the patterns of their dietary lapses and exercise habits. The problem solver feature helps users identify their biggest problem with diet/exercise and then asks a series of questions to help the app provide tailored solutions to the participant to work on. Participants randomized to MyFitnessPal will track their calorie intake and exercise daily during the intervention.
- Conditions
- Obesity
- Being tested
- Building Habits Together, Getting Healthy Together
- Keywords
- obesity, lifestyle intervention, mobile app
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Habits TogetherBehavioural
Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app.
Getting Healthy TogetherBehavioural
Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app.
| Study group | Role | What they receive |
|---|---|---|
| Building Habits Together | Experimental | The Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). Receives: Behavioral: Building Habits Together |
| Getting Healthy Together | Active comparator | The Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). Receives: Behavioral: Getting Healthy Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile App Use
Investigators will calculate the number of days participants used their assigned app
Measured: 24 weeks
Retention
Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up
Measured: 24 weeks
Engagement Per Participant in the Facebook Group
For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks.
Measured: 24 weeks
Ease of Use (Acceptability)
Participants will rate how easy it was to use their assigned app (% who strongly agree/agree)
Measured: 24 weeks
Contamination
Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program.
Measured: 24 weeks
Time Consuming (Burden)
Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree)
Measured: 24 weeks
Secondary outcomes (1)
Percentage of Baseline Weight Lost at 24 Weeks
Investigators will calculate percent weight change from baseline at 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start3 Apr 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Worcester Polytechnic Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sherry Pagoto, University of Connecticut
- Investigators
- Sherry Pagoto, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154213
- Sponsor's protocol ID
- HR22-0155
- Other IDs
- R34HL145439
- Status last verified
- Mar 2025
- First submitted
- 23 May 2023
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Habits Together Online Weight Loss Program: Pilot Trial
- ClinicalTrials.gov ID
- NCT06154213
- Acronym / sponsor ID
- HR22-0155
- Conditions
- Obesity
- Keywords
- obesity, lifestyle intervention, mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Worcester Polytechnic Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot trial is to evaluate the feasibility of a lifestyle intervention where participants will all receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app.
Detailed description
The purpose of this pilot trial is to evaluate the feasibility of a program where 70 adults with overweight or obesity will receive online weight loss counseling delivered via a private Facebook group, but be randomized to the Habit app (developed by the investigators) or MyFitnessPal, a commercial calorie tracking app. Participants randomized to the Habit app will be asked to record their weight daily, monitor their dietary temptations, plan their exercise, and solve diet and exercise related problems. The temptation tracker helps users identify triggers and track when and why those triggers lead to dietary lapses. The exercise planner allows users to plan their exercise for the week and track whether they completed or missed the exercise and why they missed it. The Habit app provides insights to users about the patterns of their dietary lapses and exercise habits. The problem solver feature helps users identify their biggest problem with diet/exercise and then asks a series of questions to help the app provide tailored solutions to the participant to work on. Participants randomized to MyFitnessPal will track their calorie intake and exercise daily during the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Building Habits Together | Experimental | Behavioral: Building Habits TogetherThe Building Habits Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the Habit app (temptation tracking, exercise planning, and problem solving features). |
| Getting Healthy Together | Active comparator | Behavioral: Getting Healthy TogetherThe Getting Healthy Together arm includes the 24-week, Facebook-delivered lifestyle intervention based on the Diabetes Prevention Program and use of the MyFitnessPal app (daily calorie tracking, exercise tracking). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 years old
- Body mass index (BMI) 27-45 kg/m2
- Wi-Fi connectivity at home
- Logs into Facebook at least 5 days per week over the past 2 weeks
- Has posted/replied on Facebook at least once a week in the past 2 weeks
Key exclusion criteria (36 listed)
- Under the age of 18 and over the age of 65
- BMI under 27 or over 45 at screening; then under 27 at the point of the first weight on scale
- Does not have Wi-Fi connectivity at home
- Does not have a Facebook account
- Does not log into Facebook at least 5 days per week over the past 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Habits TogetherPrivate, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app. | Behavioural | Building Habits Together |
| Getting Healthy TogetherPrivate, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app. | Behavioural | Getting Healthy Together |
Primary outcome
Mobile App Use
Time frame: 24 weeks
Investigators will calculate the number of days participants used their assigned app
Retention
Time frame: 24 weeks
Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up
Engagement Per Participant in the Facebook Group
Time frame: 24 weeks
For each participant, investigators will calculate total engagement in the Facebook group as defined as reactions (e.g., like, care, wow, etc.), replies, posts, and poll votes during the 24-week program. Then we will calculate mean or median engagement per participant over 24 weeks.
Ease of Use (Acceptability)
Time frame: 24 weeks
Participants will rate how easy it was to use their assigned app (% who strongly agree/agree)
Contamination
Time frame: 24 weeks
Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program.
Time Consuming (Burden)
Time frame: 24 weeks
Participants will rate their assigned app in terms of whether they felt it took too much time out of their day (% who strongly agree/agree)
1 secondary outcome
Percentage of Baseline Weight Lost at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry Pagoto, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Habits Together and Getting Healthy Together in people with Obesity, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile App Use (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.