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

Drexel University logo

Drexel University

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Friend/Family Share On
Behavioral: Friend/Family Share Off
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Coach Share Off
Behavioral: Coach Share On
Behavioral: Group Share On
Behavioral: Group Share Off

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05180448
1R01DK129300-01 (U.S. NIH Grant/Contract)
R01DK129300

Details and patient eligibility

About

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.

Full 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 = 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. 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 text messages with the coach, with a small group of fellow group participants, and with a friend or family member outside of the program. Text 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.

Enrollment

322 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

322 participants in 8 patient groups

Coach Share On + Group Share On + Friend/Family Share On
Experimental group
Treatment:
Behavioral: Group Share On
Behavioral: Coach Share On
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share On
Coach Share On + Group Share On + Friend/Family Share Off
Experimental group
Treatment:
Behavioral: Group Share On
Behavioral: Coach Share On
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share Off
Coach Share On + Group Share Off + Friend/Family Share On
Experimental group
Treatment:
Behavioral: Group Share Off
Behavioral: Coach Share On
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share On
Coach Share On + Group Share Off + Group Share Off
Experimental group
Treatment:
Behavioral: Group Share Off
Behavioral: Coach Share On
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share Off
Coach Share Off + Group Share On + Friend/Family Share On
Experimental group
Treatment:
Behavioral: Group Share On
Behavioral: Coach Share Off
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share On
Coach Share Off + Group Share On + Friend/Family Share Off
Experimental group
Treatment:
Behavioral: Group Share On
Behavioral: Coach Share Off
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share Off
Coach Share Off + Group Share Off + Friend/Family Share On
Experimental group
Treatment:
Behavioral: Group Share Off
Behavioral: Coach Share Off
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share On
Coach Share Off + Group Share Off + Friend/Family Share Off
Experimental group
Treatment:
Behavioral: Group Share Off
Behavioral: Coach Share Off
Behavioral: Behavioral Weight Loss Treatment
Behavioral: Friend/Family Share Off

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Research Coordinator

Data sourced from clinicaltrials.gov

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