Building Habits Together Online Weight Loss Program

Obesity Clinical Trial

Official title:

Building Habits Together Online Weight Loss Program: Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154213
• Other study ID #: HR22-0155
• Secondary ID: R34HL145439
• Status: Completed
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Building Habits Together
Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app.
• Getting Healthy Together
Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	National Heart, Lung, and Blood Institute (NHLBI), Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobile app use	Investigators will calculate the number of uses for each app feature for each participant	24 weeks
Primary	Retention	Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up	24 weeks
Primary	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.	24 weeks
Primary	Intervention Satisfaction	Participants will rate how easy it was to use their assigned app (% who strongly agree/agree versus neutral/disagree/strongly disagree)	24 weeks
Primary	Contamination	Investigators will report the percent of participants in the Habit condition that used MyFitnessPal or other calorie tracking apps during the program.	24 weeks
Primary	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 versus neutral/disagree/strongly disagree)	24 weeks
Secondary	Percent weight change	Investigators will calculate percent weight change from baseline at 24 weeks	24 weeks