Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss (FitLink)
Sharing Digital Self-Monitoring Data With Others to Enhance Long-Term Weight Loss: A Randomized Trial Using a Factorial Design
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Research Coordinator
- Phone Number: 215-553-7161
- Email: nam365@drexel.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Coach Share On + Group Share On + Friend/Family Share On
|
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
|
|
Experimental: Coach Share On + Group Share On + Friend/Family Share Off
|
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
|
|
Experimental: Coach Share On + Group Share Off + Friend/Family Share On
|
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.
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
|
|
Experimental: Coach Share On + Group Share Off + Group Share Off
|
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
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.
|
|
Experimental: Coach Share Off + Group Share On + Friend/Family Share On
|
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
|
|
Experimental: Coach Share Off + Group Share On + Friend/Family Share Off
|
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
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.
|
|
Experimental: Coach Share Off + Group Share Off + Friend/Family Share On
|
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.
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
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.
|
|
Experimental: Coach Share Off + Group Share Off + Friend/Family Share Off
|
Standard Behavioral Weight Loss Treatment (remotely delivered)
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 0 month, 3 month, 6 month, 12 month, 24 month
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: 0 month, 3 month, 6 month, 12 month, 24 month
|
Minutes per week of moderate-to-vigorous PA will be measured by using FitBit.
Steps per day from the Fitbit also will be examined.
|
0 month, 3 month, 6 month, 12 month, 24 month
|
|
Calorie Intake
Time Frame: 0 month, 3 month, 6 month, 12 month, 24 month
|
Average calorie intake over 7 days will be derived from the Fitbit digital food log as a secondary outcome.
|
0 month, 3 month, 6 month, 12 month, 24 month
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Supportive Accountability for Weight Control
Time Frame: 0 months, 6 month, 12 month, 24 month
|
(mediator, moderator) will be measured with the Supportive Accountability Measure and the Supportive Accountability Inventory
|
0 months, 6 month, 12 month, 24 month
|
|
Self-regulation value of program components
Time Frame: 3 months, 6 month, 12 month, 24 month
|
(Mediator, moderator) will be measured with items, adapted from previous research, that ask index participants to rate how helpful each program component is reflecting on how their progress compares to their goals, planning short-term behaviors and strategy use, and evaluating if current goals should be adjusted.
|
3 months, 6 month, 12 month, 24 month
|
|
Self-monitoring
Time Frame: Calculated continuously for 24 months
|
(Mediator, moderator) will be objectively measured as the number of days in which digital devices were used to measure weight, record eating, or PA.
|
Calculated continuously for 24 months
|
|
social comparison
Time Frame: 0, 12, 24 months
|
(Mediator, moderator) will be measured with the Iowa-Netherlands Comparison Orientation Measure, with items modified to be focused on the lifestyle modification group.
|
0, 12, 24 months
|
|
Perceived Social Support
Time Frame: 0 months, 6 month, 12 month, 24 month
|
(Mediator, moderator) assessed with the Social Support for Healthy Behaviors Measure.
Index participants will report the frequency with which friends and family members engaged in behaviors that support or undermine healthy eating and physical activity in the past month.
|
0 months, 6 month, 12 month, 24 month
|
|
Relationship Quality
Time Frame: 0, 3, 6, 12, 24 months
|
(Moderator, moderator) will be measured with items adapted from the client version of the Working Alliance Inventory-Bond Subscale.
Ratings will be completed separately for the relationship with the coach, the lifestyle modification group, and the designated friend/family support person, yielding scores for each party
|
0, 3, 6, 12, 24 months
|
|
Weight Self-Stigma
Time Frame: 0 months
|
(moderator) will be measured with items, adapted from previous research, that assess for weight self-stigma.
|
0 months
|
|
Friend/family characteristics
Time Frame: 0, 3, 6, 12, 24 months
|
(mediator, moderator) Items to characterize the friend/family member relationship, such as their age, gender, body size, perceived healthfulness of diet, interest in weight loss, frequency of communication, comfort discussion lifestyle modification with them, reactions to weight-related communication
|
0, 3, 6, 12, 24 months
|
|
Small group dynamic
Time Frame: 3, 6, 12, 24 months
|
(mediator, moderator) Items to characterize the small group dynamic, including frequency of communication and reactions to communication
|
3, 6, 12, 24 months
|
|
Demographic variables
Time Frame: 0 months
|
(moderator) Items to characterize the participant, including age, sex, race, ethnicity, education level, household composition
|
0 months
|
|
Coach characteristics
Time Frame: 0 months
|
(moderator) Coach level of behavioral weight loss experience (# of sessions previously conducted) and level of education will be calculated
|
0 months
|
|
Method of message delivery
Time Frame: 0 months
|
(moderator) Whether text messages were delivered to app (Wave 1 and 2) or via SMS (Wave 3 and 4) will be examined to determine if this impacts intervention efficacy
|
0 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Meghan L Butryn, PhD, Drexel University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- R01DK129300 (U.S. NIH Grant/Contract)
- 1R01DK129300-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.