Clinical trial NCT03337139: FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability
Official title: Improving Weight Loss Maintenance by Using Digital Data Sharing to Provide Responsive Support and Accountability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Overweight and Obesity
Weight Loss
Keywords: Weight Loss
Obesity
Overweight
Behavioral Weight Loss
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Office of Behavioral and Social Sciences Research (OBSSR)
First posted: 2017-11-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most adults in the U.S. are overweight or obese and find maintenance of weight loss difficult. This study is designed to aid in the development of a lifestyle modification program that can facilitate weight loss maintenance, without requiring long-term visits to a clinic for maintenance treatment.

Detailed description: In a lifestyle modification program, contact with an interventionist (e.g., weight loss coach) creates a sense of supportive accountability that can facilitate behavior change and weight loss. Sustaining a strong sense of supportive accountability after face-to-face intervention contact ends has the potential to improve outcomes during the notoriously difficult weight loss maintenance period. One innovative way of facilitating supportive accountability is providing participants with digital tools that objectively measure weight and physical activity and track food intake in real-time, making the data from those tools automatically and continuously available to coaches, and designing the timing and content of intervention contacts such that they are responsive to the shared data. Although tools that allow for data sharing from sensors and Internet-based applications are readily available, the ways in which they are integrated into intervention contacts in a lifestyle modification program are not yet optimized, and research has not systematically evaluated the effect of data sharing on behavior. Overweight and obese participants (n = 90) will be recruited from the community for a small randomized controlled trial in order to test the feasibility, acceptability, efficacy, and mechanisms of action of a lifestyle modification intervention enhanced with data sharing. In weeks 1-12 of the program (i.e., Phase I), all participants will attend 12 weekly, face-to-face, group-based behavioral treatment sessions to induce weight loss. Participants will be provided with a wireless body weight scale, physical activity sensor, and digital food record app and instructed to use them daily use for self-monitoring purposes. In Phase II (weeks 13-52), participants will be randomly assigned to the standard (LM) or enhanced version of remote lifestyle modification (LM+SHARE). Neither condition will have face-to-face intervention contact during Phase II; remote intervention contact will consist of brief phone calls and text messages provided by the participant's coach. Participants in both conditions will be prescribed continued daily use of the three self-monitoring devices. In the standard LM condition, no digital data from these devices will be directly shared with coaches; intervention encounters will be informed only by the infrequent, delayed self-report of participants (which is the current standard of long-term obesity care), and timing of text messages will be fixed. In LM+SHARE, the digital tools will automatically and continuously transmit body weight, physical activity, and food record data to the coach. In LM+SHARE, supportive accountability will be enhanced in three ways: 1) participants will receive automated alerts after coaches view their data, 2) timing of personalized text messages from coaches will be responsive to clinically notable change in weight, physical activity, calorie intake, or use of scale, physical activity sensor, or food record tool, and 3) content of the text messages and phone calls will be informed by the digital data the coach has viewed, as well as the expectation that the coach will continue viewing data in order to provide ongoing support. Assessments will be completed at 0, 12, 26, and 52 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-70 years with a BMI of 25-45 kg/m2 and weight \<160 kg
* Access to a smartphone
* Satisfactory completion of all enrollment procedures
* Ability to engage in physical activity (i.e. can walk at least 2 blocks without stopping for rest)

Exclusion Criteria:

* Medical condition (i.e. acute coronary syndrome, type 1 diabetes, renal failure) or psychiatric condition (i.e. active substance abuse, eating disorder) that may:

  * Pose a risk to the participant during the intervention
  * Cause a change in weight
  * Limit ability to comply with the behavioral recommendations of the program
* Pregnant or planning pregnancy in the next 1 year
* Planned move out of the Philadelphia area during the data collection period
* Use of a pacemaker (incompatible with wireless scale technology)
* Recently began or changed the dosage of a medication that can cause significant change in weight
* History of bariatric surgery
* Weight loss of \> 10% in the previous 3 months

Primary outcomes:
measure: Change in Body Weight
timeFrame: 0, 13, 26, 52 weeks
measure: Change in Physical Activity
timeFrame: 13, 52 weeks
measure: Number of Participants Retained
timeFrame: 26, 52 weeks
measure: Number of Completed Treatment Contacts
timeFrame: 52 weeks
measure: Treatment Acceptability Questionnaire (TAQ)
timeFrame: 52 weeks
Secondary outcomes:
measure: Self-monitoring Engagement
timeFrame: 13-52 weeks
measure: Perceived Accountability
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Meghan L Butryn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butryn ML, Martinelli MK, Crane NT, Godfrey K, Roberts SR, Zhang F, Forman EM. Counselor Surveillance of Digital Self-Monitoring Data: A Pilot Randomized Controlled Trial. Obesity (Silver Spring). 2020 Dec;28(12):2339-2346. doi: 10.1002/oby.23015. Epub 2020 Oct 23.
citation: Schumacher LM, Martinelli MK, Convertino AD, Forman EM, Butryn ML. Weight-Related Information Avoidance Prospectively Predicts Poorer Self-Monitoring and Engagement in a Behavioral Weight Loss Intervention. Ann Behav Med. 2021 Mar 16;55(2):103-111. doi: 10.1093/abm/kaaa034.