OverweightFitLinkNCT05180448

Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss

A study testing Coach Share On, Group Share On and Friend/Family Share On in people with Overweight and Obesity, run by Drexel University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Overweight, Obesity
What is being tested?: Coach Share On, Group Share On and Friend/Family Share On
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 321 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2022to 30 Jul 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals must be of overweight or obese BMI (27-50 kg/m2)
Individuals must be adults (aged 18-70)
Able to engage in physical activity (defined as walking two city blocks without stopping)
Access and willingness to use a smartphone and internet
Has one adult friend or family member who indicates willingness to serve in a support role
Satisfactory completion of all enrollment procedures
English Speaking

Who cannot join

Medical or psychiatric condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight, or limit ability to comply with the program or participate appropriately in group-based treatment
Currently pregnant or breastfeeding, or planning to become pregnant in the next 24 months
Use of insulin or a medication that can cause significant change in weight
History of bariatric surgery
Weight loss of greater than or equal to 5% in the previous 3 months
Weight loss of greater than or equal to 10% in the past 3 years that is currently being maintained

Trial locations and contacts

1 site in 1 country.

United States1 site

Drexel University
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss: A Randomized Trial Using a Factorial Design

Read the detailed description

Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others on goal progress. This study proposes that sharing digital data with other parties has the potential to improve long-term weight loss. The proposed study will enroll adults ("index participants") (N = 321) with overweight/obesity in a 24-month LM program and instruct them to use digital tools for self-monitoring of weight, physical activity, and eating on a daily basis. Groups will meet remotely each week in months 1-3 to initiate weight loss. In months 4-24, intervention contact will be remote and will include the following: quarterly group meetings held via videoconference; brief phone calls with the coach held twice per quarter; and monthly messages with the coach, with a small group of fellow group participants, and with a friend or family member outside of the program. Message content will vary according to treatment condition, i.e. three types of data sharing partnerships: Coach Share, Group Share, and Friend/Family Share. Outcomes will be measured at months 0, 3, 6, 12, and 24. Primary aims include determining if Coach Share, Group Share, and Friend/ Family Share each improve long-term weight loss, PA, and calorie intake, and examining if effects are additive when participants are assigned to engage in more than one type of data sharing partnership. The secondary aim is to explore mediators and moderators of intervention effects. The tertiary aim is to determine how the quality of relationship with coach, group members, and friends/family member over time may differentially moderate treatment effects and predict data sharing efficacy. As digital technology makes data sharing increasingly feasible, it is critical to determine how to optimize these partnerships to improve long-term outcomes in LM.

Conditions: Overweight, Obesity
Being tested: Coach Share On, Group Share On, Friend/Family Share On, Coach Share Off, Group Share Off
Keywords: weight loss, lifestyle modification, behavioral modification, overweight, obesity
Medical subject headings: Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coach Share OnBehavioural
If an index participant is randomized to have Coach Share ON, the coach will have continuous access to objective, real-time, detailed device data, and address data directly in all individual interactions with index participants (groups, individual weigh-ins, phone calls, texts), conveying that they are closely monitoring progress.
Group Share OnBehavioural
If Group Share is ON, participants in a given LM group will view and respond to aspects of each other's self-monitoring device data in their small-group text messages. Each small group participant's data will be highlighted one day of the month, and content from the Group Share Off message library also will be sent.
Friend/Family Share OnBehavioural
Index participants who are randomized to have Friend/Family Share ON will give their friend or family member access to their self-monitoring data. Text messages sent by the program bot, which includes the index participant and friend/family member, will use a similar format as described in Group Share ON. The friend or family member will be trained to respond to data in ways that enhance the participant's motivation and self-regulation.
Coach Share OffBehavioural
Among index participants who are randomized to have Coach Share OFF, the coach will have no access to their device data. Index participants will be explicitly told their coach does not have data access. During groups and phone calls, the participant will self-report progress, and goal setting will be based on that self-report. Text messages from the coach will be personalized in the OFF condition, as they are when coach data sharing is ON, though these messages will not be informed by device data. Instead, text messages will provide a reminder of key goals and strategies discussed in the previous phone call and provide encouragement for participant efforts.
Group Share OffBehavioural
Among index participants randomized to have Group Share OFF, supportive accountability will not be the target of participant interactions and no data will be shared with LM program peers. Instead, once weekly prompts for small group text exchanges will encourage index participants to provide social support (primarily of the informational type) to each other. Index participants will be explicitly told that they should not include information on goal progress such as weight change or minutes of PA.
Friend/Family Share OffBehavioural
If an index participant is randomized to Friend/Family Share OFF, the text messages from the bot will prompt the participant and friend/family member to communicate about the LM program; those messages will be standardized, except for names, and will not be tailored to index participant progress. Index participants will be instructed to refrain from sharing any device data with friends or family members.
Behavioral Weight Loss TreatmentBehavioural
Standard Behavioral Weight Loss Treatment (remotely delivered)

Study groups in NCT05180448
Study group	Role	What they receive
Coach Share On + Group Share On + Friend/Family Share On	Experimental	Not described Receives: Behavioral: Coach Share On; Behavioral: Group Share On; Behavioral: Friend/Family Share On; Behavioral: Behavioral Weight Loss Treatment
Coach Share On + Group Share On + Friend/Family Share Off	Experimental	Not described Receives: Behavioral: Coach Share On; Behavioral: Group Share On; Behavioral: Friend/Family Share Off; Behavioral: Behavioral Weight Loss Treatment
Coach Share On + Group Share Off + Friend/Family Share On	Experimental	Not described Receives: Behavioral: Coach Share On; Behavioral: Friend/Family Share On; Behavioral: Group Share Off; Behavioral: Behavioral Weight Loss Treatment
Coach Share On + Group Share Off + Group Share Off	Experimental	Not described Receives: Behavioral: Coach Share On; Behavioral: Group Share Off; Behavioral: Friend/Family Share Off; Behavioral: Behavioral Weight Loss Treatment
Coach Share Off + Group Share On + Friend/Family Share On	Experimental	Not described Receives: Behavioral: Group Share On; Behavioral: Friend/Family Share On; Behavioral: Coach Share Off; Behavioral: Behavioral Weight Loss Treatment
Coach Share Off + Group Share On + Friend/Family Share Off	Experimental	Not described Receives: Behavioral: Group Share On; Behavioral: Coach Share Off; Behavioral: Friend/Family Share Off; Behavioral: Behavioral Weight Loss Treatment
Coach Share Off + Group Share Off + Friend/Family Share On	Experimental	Not described Receives: Behavioral: Friend/Family Share On; Behavioral: Coach Share Off; Behavioral: Group Share Off; Behavioral: Behavioral Weight Loss Treatment
Coach Share Off + Group Share Off + Friend/Family Share Off	Experimental	Not described Receives: Behavioral: Coach Share Off; Behavioral: Group Share Off; Behavioral: Friend/Family Share Off; Behavioral: Behavioral Weight Loss Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Weight From Baseline (0 Month)
Weight was measured via participants at home using a wireless body weight scale provided by the study, with data transmitted directly to the research team via API. Participants were instructed to place the scale on flat, hard surface and weigh upon waking, without clothes, after using the bathroom.
Measured: 0 month, 3 month, 6 month, 12 month, 24 month

Secondary outcomes (3)

Physical Activity
Minutes per week of moderate-to-vigorous PA will be measured by using FitBit.
Measured: 0 month, 3 month, 6 month, 12 month, 24 month
Calorie Intake
Average calorie intake over 7 days will be derived from the Fitbit digital food log as a secondary outcome.
Measured: 12 months
Steps Per Day
Measured with accelerometer
Measured: 0, 3, 6, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202230 Jul 2025

First posted6 Jan 2022
Study start3 Jan 2022
Primary completion30 Jul 2025
Study completion30 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OverweightStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: This is a 2x2x2 design. There are three factors, each with two levels: ON vs OFF
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05180448
Sponsor's protocol ID: R01DK129300
Other IDs: 1R01DK129300-01
Acronym: FitLink
Status last verified: Oct 2026
First submitted: 20 Sep 2021
Last updated: 7 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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