NCT06154213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 30, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

May 23, 2023

Results QC Date

April 26, 2024

Last Update Submit

March 18, 2025

Conditions

Keywords

obesitylifestyle interventionmobile app

Outcome Measures

Primary Outcomes (6)

  • Mobile App Use

    Investigators will calculate the number of days participants used their assigned app

    24 weeks

  • Retention

    Investigators will calculate retention as the proportion of participants who provide weight data at the 24 week follow-up

    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.

    24 weeks

  • Ease of Use (Acceptability)

    Participants will rate how easy it was to use their assigned app (% who strongly agree/agree)

    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.

    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)

    24 weeks

Secondary Outcomes (1)

  • Percentage of Baseline Weight Lost at 24 Weeks

    24 weeks

Study Arms (2)

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).

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).

Behavioral: Getting Healthy Together

Interventions

Private, hidden Facebook group "Building Habits Together" includes 24 weeks on content based on the Diabetes Prevention Program and the Habit app.

Building Habits Together

Private, hidden Facebook group "Getting Healthy Together" includes 24 weeks on content based on the Diabetes Prevention Program and the MyFitnessPal app.

Getting Healthy Together

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sherry Pagoto, PhD
Organization
University of Connecticut

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
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2023

First Posted

December 4, 2023

Study Start

April 3, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

March 30, 2025

Results First Posted

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations