NCT02656680

Brief Summary

In a pilot randomized trial of 160 obese participants, investigators will test the feasibility of a behavioral weight loss program delivered entirely via Facebook. We will recruit in 2 separate waves of 80 participants each. Participants will be randomized to: 1) a condition with study participants only or 2) to a condition they will be able to invite their friends into (wave 1) or one in which the study team keeps recruitment open to allow enrollment through week 8 (wave 2). All participants will receive behavioral counseling via the private Facebook group from the coaches who are present on the network daily. Participants will track their diet and exercise via a free commercial mobile app.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 16, 2021

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

January 7, 2016

Results QC Date

February 22, 2021

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Engagement

    Number of Facebook "likes" and other reactions, replies, posts, and polls per participant during the 16 week program.

    4 months

  • Retention

    The number of participants who complete the follow-up assessment in each condition.

    4 months

  • Number of Participants Rating the Intervention 'Acceptable

    Participants will rate acceptability of the online intervention. Acceptability was assessed with a single item during the follow-up survey: "How likely are you to recommend the program to a friend?" (responses on a 5-point Likert scale from not at all likely to very likely). Acceptability was categorized into acceptable, defined as responses of a little bit likely, somewhat likely, likely, and very likely, and unacceptable was defined as response of not at all likely.

    4 months

Secondary Outcomes (2)

  • Percent Weight Loss

    Baseline to 4 months

  • Diet

    4 Months

Study Arms (3)

Continuous Enrollment (Randomized)

EXPERIMENTAL

The Continuous Enrollment is a Facebook-delivered weight loss intervention. Participants in this arm were randomized to this Facebook group and started the intervention together. For this group, the study team continued to enroll participants through week 8.

Behavioral: Continuous Enrollment

Closed Enrollment (Randomized)

ACTIVE COMPARATOR

Closed Enrollment is a Facebook-delivered weight loss intervention. Participants in this arm were randomized to this Facebook group and started the intervention together. No additional participants were added to this group during the study.

Behavioral: Closed Enrollment

Continuous Enrollment (Non-Randomized)

OTHER

The Continuous Enrollment is a Facebook-delivered weight loss intervention. For this group, the study team continued to enroll participants through week 8. This arm captures only those participants that were added to the group during these 8 weeks. They were enrolled in the study after the original 80 participants were randomized.

Behavioral: Continuous Enrollment

Interventions

Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8.

Also known as: Open Group
Continuous Enrollment (Non-Randomized)Continuous Enrollment (Randomized)

Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.

Also known as: Closed Group
Closed Enrollment (Randomized)

Eligibility Criteria

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

You may qualify if:

  • Participants must be:
  • years of age;
  • Have a BMI 27-45 kg/m²;
  • Lives in the United States; and
  • Have daily internet access;

You may not qualify if:

  • Does not post on Facebook at least once per week
  • Comments on someone else's post on Facebook less than once per week
  • Does not currently use a smartphone;
  • Is not familiar with using phone apps;
  • Pregnant and/or lactating;
  • Meets criteria for severe depression on the Patient Health Questionnaire (PHQ-9) (score of \>20);
  • Had bariatric surgery, plans to during the study;
  • Has had a weight loss of 5% or greater within previous 3 months;
  • Meets criteria for Binge Eating Disorder;
  • Condition that precludes lifestyle changes (i.e. a condition that prevents physical activity increase or dietary changes);
  • Medications affecting weight;
  • Incapable of walking ¼ mile without stopping;
  • Type 1 or 2 diabetes;
  • Participated in previous weight loss studies under the PI;
  • Has concerns about being in a Facebook group with other faculty, staff, or students from the University of Connecticut;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (2)

  • Xu R, Divito J, Bannor R, Schroeder M, Pagoto S. Predicting Participant Engagement in a Social Media-Delivered Lifestyle Intervention Using Microlevel Conversational Data: Secondary Analysis of Data From a Pilot Randomized Controlled Trial. JMIR Form Res. 2022 Jul 28;6(7):e38068. doi: 10.2196/38068.

  • Pagoto SL, Schroeder MW, Xu R, Waring ME, Groshon L, Goetz JM, Idiong C, Troy H, DiVito J, Bannor R. A Facebook-Delivered Weight Loss Intervention Using Open Enrollment: Randomized Pilot Feasibility Trial. JMIR Form Res. 2022 May 6;6(5):e33663. doi: 10.2196/33663.

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Sherry Pagoto
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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 15, 2016

Study Start

February 1, 2018

Primary Completion

February 20, 2020

Study Completion

March 31, 2020

Last Updated

March 21, 2024

Results First Posted

March 16, 2021

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations