NCT02646618

Brief Summary

The present study is a non-inferiority trial comparing the efficacy of a lifestyle intervention delivered entirely via an online social network to a traditional lifestyle intervention delivered via group meetings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
329

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 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 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 5, 2021

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

3.9 years

First QC Date

January 4, 2016

Results QC Date

February 26, 2021

Last Update Submit

November 21, 2023

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (3)

  • Weight

    A digital scale (Scaletronix, Model-5002) will be used to record weight

    Baseline

  • Percent Weight Change

    A digital scale (Scaletronix, Model-5002) will be used to record weight

    Baseline to 6-months

  • Percent Weight Change

    A digital scale (Scaletronix, Model-5002) will be used to record weight

    Baseline to 12-months

Secondary Outcomes (46)

  • Cost Associated With Intervention

    12-months

  • Time Spent During Intervention

    12-months

  • Retention at Follow-up

    12-months

  • Acceptability of the Intervention

    6-months

  • Burden of Intervention

    6-months

  • +41 more secondary outcomes

Study Arms (2)

Get Social

ACTIVE COMPARATOR

Get Social participants will receive a weight loss intervention in a "protected" Twitter group. The intervention content will be structured to deliver 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.

Behavioral: Get SocialDevice: Smartphone

Traditional

ACTIVE COMPARATOR

Participants will attend weight loss groups weekly for 8 weeks, then biweekly for 16 weeks, then monthly between months 6 and 12. 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.

Behavioral: TraditionalDevice: Smartphone

Interventions

Get SocialBEHAVIORAL

Online-delivered weight loss intervention

Get Social
TraditionalBEHAVIORAL

Group-delivered weight loss intervention

Traditional
SmartphoneDEVICE

A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants

Get SocialTraditional

Eligibility Criteria

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

You may qualify if:

  • Smartphone users
  • Ages 18-65
  • Body Mass Index (BMI) 27-45
  • Must currently log into a social media platform on a daily basis basis and engage (like, reply, post) at least 4 days per week.
  • Participants will be excluded if they:
  • Do not have a smartphone;
  • Are unable to get medical clearance from their Primary Care Physician (PCP);
  • Have plans to move during study;
  • Are not interested in losing weight;
  • Have Type 1 or uncontrolled 2 Diabetes (as determined by PCP);
  • Have medical conditions that would prevent increasing physical activity or making dietary changes;
  • Are pregnant/lactating or plans to become pregnant during study;
  • Are currently taking medication affecting weight;
  • Currently participating in a weight loss program or using an online social network to assist them with weight loss (e.g. Weight Watchers, Sparkpeople, etc);
  • Unable to walk at least ¼ mile unaided without stopping;
  • +14 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 (3)

  • Pagoto SL, Goetz JM, Xu R, Wang ML, Palmer L, Lemon SC. Randomized non-inferiority trial comparing an asynchronous remotely-delivered versus clinic-delivered lifestyle intervention. Int J Obes (Lond). 2025 Jan;49(1):76-83. doi: 10.1038/s41366-024-01617-0. Epub 2024 Aug 27.

    PMID: 39191926DERIVED

  • Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.

    PMID: 34544560DERIVED

  • Wang ML, Waring ME, Jake-Schoffman DE, Oleski JL, Michaels Z, Goetz JM, Lemon SC, Ma Y, Pagoto SL. Clinic Versus Online Social Network-Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 11;6(12):e243. doi: 10.2196/resprot.8068.

    PMID: 29229591DERIVED

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
Sherry.Pagoto@uconn.edu
8604868979

Study Officials

  • Sherry Pagoto

    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 4, 2016

First Posted

January 5, 2016

Study Start

April 1, 2016

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

November 24, 2023

Results First Posted

May 5, 2021

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)