FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability
Improving Weight Loss Maintenance by Using Digital Data Sharing to Provide Responsive Support and Accountability
2 other identifiers
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Nov 2017
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
November 7, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedStudy Start
First participant enrolled
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedJanuary 5, 2021
December 1, 2020
1.5 years
November 7, 2017
October 30, 2020
December 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in Body Weight
Objectively measured in the research clinic at each time point on a scale. Reported as weight change in kg, where negative numbers reflect weight loss and positive numbers reflect weight gain.
0, 13, 26, 52 weeks
Change in Physical Activity
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
13, 52 weeks
Number of Participants Retained
Feasibility and acceptability metric of retention.
26, 52 weeks
Number of Completed Treatment Contacts
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
52 weeks
Treatment Acceptability Questionnaire (TAQ)
Feasibility and acceptability metric of scores on the TAQ. Items on the TAQ consisted of 11 questions on a 7 point Likert scale asking about helpfulness and acceptability of treatment components. Items are summed to yield a total score that can range from 11-77 with higher numbers indicated higher acceptability.
52 weeks
Secondary Outcomes (2)
Self-monitoring Engagement
13-52 weeks
Perceived Accountability
52 weeks
Study Arms (2)
Lifestyle Modification
ACTIVE COMPARATORThree months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.
Lifestyle Modification + Share
EXPERIMENTALThree 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drexel University
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
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.
PMID: 33098278DERIVEDSchumacher 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.
PMID: 32491152DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Low proportion of men and adults over age 70 limits generalizability; calls and texts were not qualitatively analyzed nor rated for treatment fidelity; length of each telephone session was not measured; it is unknown to what extent participants shared device data with friends/family/other participants and threatened contamination; low power.
Results Point of Contact
- Title
- Dr. Meghan Butryn
- Organization
- Drexel University
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan L Butryn, Ph.D.
Drexel University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 7, 2017
First Posted
November 8, 2017
Study Start
November 17, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
January 5, 2021
Results First Posted
January 5, 2021
Record last verified: 2020-12