FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability

NCT ID: NCT03337139

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2019-05-31

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.

Conditions

Obesity; Overweight; Overweight and Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Modification

Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.

Group Type: ACTIVE_COMPARATOR

Gold Standard Behavior Therapy for Weight Loss

Intervention Type: BEHAVIORAL

Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.

Standard Remote Behavior Therapy for Weight Loss

Intervention Type: BEHAVIORAL

Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.

Lifestyle Modification + Share

Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians.

Group Type: EXPERIMENTAL

Gold Standard Behavior Therapy for Weight Loss

Intervention Type: BEHAVIORAL

Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.

Digital Data Sharing Behavior Therapy for Weight Loss

Intervention Type: BEHAVIORAL

Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.

Interventions

Gold Standard Behavior Therapy for Weight Loss

Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.

Intervention Type: BEHAVIORAL

Standard Remote Behavior Therapy for Weight Loss

Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.

Intervention Type: BEHAVIORAL

Digital Data Sharing Behavior Therapy for Weight Loss

Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Office of Behavioral and Social Sciences Research (OBSSR)

NIH

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Meghan Butryn

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meghan L Butryn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33098278 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32491152 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21DK112741

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1611004954

Identifier Type: -

Identifier Source: org_study_id