Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss
FitLink
2 other identifiers
interventional
322
1 country
1
Brief Summary
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 = 320) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedSeptember 30, 2025
September 1, 2025
3.6 years
September 20, 2021
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
Weight will be measured using a wireless scale. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) remove errant weights (e.g., \>1 kg change in 1 day).
0 month, 3 month, 6 month, 12 month, 24 month
Secondary Outcomes (2)
Physical Activity
0 month, 3 month, 6 month, 12 month, 24 month
Calorie Intake
0 month, 3 month, 6 month, 12 month, 24 month
Other Outcomes (12)
Perceived Supportive Accountability for Weight Control
0 months, 6 month, 12 month, 24 month
Self-regulation value of program components
3 months, 6 month, 12 month, 24 month
Self-monitoring
Calculated continuously for 24 months
- +9 more other outcomes
Study Arms (8)
Coach Share On + Group Share On + Friend/Family Share On
EXPERIMENTALCoach Share On + Group Share On + Friend/Family Share Off
EXPERIMENTALCoach Share On + Group Share Off + Friend/Family Share On
EXPERIMENTALCoach Share On + Group Share Off + Group Share Off
EXPERIMENTALCoach Share Off + Group Share On + Friend/Family Share On
EXPERIMENTALCoach Share Off + Group Share On + Friend/Family Share Off
EXPERIMENTALCoach Share Off + Group Share Off + Friend/Family Share On
EXPERIMENTALCoach Share Off + Group Share Off + Friend/Family Share Off
EXPERIMENTALInterventions
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.
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.
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.
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.
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.
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drexel University
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan L Butryn, PhD
Drexel University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessors will be blind to condition.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2021
First Posted
January 6, 2022
Study Start
January 3, 2022
Primary Completion
July 30, 2025
Study Completion
July 30, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share