Clinical trial NCT06154213: Building Habits Together Online Weight Loss Program
Official title: Building Habits Together Online Weight Loss Program: Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
lifestyle intervention
mobile app
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Mobile App Use
timeFrame: 24 weeks
measure: Retention
timeFrame: 24 weeks
measure: Engagement Per Participant in the Facebook Group
timeFrame: 24 weeks
measure: Ease of Use (Acceptability)
timeFrame: 24 weeks
measure: Contamination
timeFrame: 24 weeks
measure: Time Consuming (Burden)
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Baseline Weight Lost at 24 Weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Sherry Pagoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: