FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability
Primary Purpose
Obesity, Overweight, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gold Standard Behavior Therapy for Weight Loss
Standard Remote Behavior Therapy for Weight Loss
Digital Data Sharing Behavior Therapy for Weight Loss
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight Loss, Obesity, Overweight, Behavioral Weight Loss
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
Sites / Locations
- Drexel University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lifestyle Modification
Lifestyle Modification + Share
Arm Description
Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.
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.
Outcomes
Primary Outcome Measures
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.
Change in Physical Activity
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
Number of Participants Retained
Feasibility and acceptability metric of retention.
Number of Completed Treatment Contacts
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
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.
Secondary Outcome Measures
Self-monitoring Engagement
Use of digital devices; percent of days during which weight, food, and steps were counted in Phase II. Percent calculated for each group (LM vs. LM+Share) and not for individual participants. We determined percent to be the metric that would be most easily interpreted and it accounted for any possible variability in total number of days of observations.
Perceived Accountability
Change in "Perceptions of Accountability" subscale of the Supportive Accountability Scale. The measure used was a 10-item scale on which participants rated the extent to which they agreed with statements on a 7-point likert scale. A total score was generated by summing scores from individual items. Total scores ranged from 10-70 with higher scorings indicating higher perceived accountability. The outcome measure reported here is the change in total score on this measure (decrease) across Phase II where a negative score reflects a decrease in perceived accountability.
Full Information
NCT ID
NCT03337139
First Posted
November 7, 2017
Last Updated
December 10, 2020
Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Behavioral and Social Sciences Research (OBSSR)
1. Study Identification
Unique Protocol Identification Number
NCT03337139
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Behavioral and Social Sciences Research (OBSSR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Overweight and Obesity, Weight Loss
Keywords
Weight Loss, Obesity, Overweight, Behavioral Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Modification
Arm Type
Active Comparator
Arm Description
Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.
Arm Title
Lifestyle Modification + Share
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gold Standard Behavior Therapy for Weight Loss
Intervention Description
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
Intervention Name(s)
Standard Remote Behavior Therapy for Weight Loss
Intervention Description
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
Intervention Name(s)
Digital Data Sharing Behavior Therapy for Weight Loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
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.
Time Frame
0, 13, 26, 52 weeks
Title
Change in Physical Activity
Description
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
Time Frame
13, 52 weeks
Title
Number of Participants Retained
Description
Feasibility and acceptability metric of retention.
Time Frame
26, 52 weeks
Title
Number of Completed Treatment Contacts
Description
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
Time Frame
52 weeks
Title
Treatment Acceptability Questionnaire (TAQ)
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Self-monitoring Engagement
Description
Use of digital devices; percent of days during which weight, food, and steps were counted in Phase II. Percent calculated for each group (LM vs. LM+Share) and not for individual participants. We determined percent to be the metric that would be most easily interpreted and it accounted for any possible variability in total number of days of observations.
Time Frame
13-52 weeks
Title
Perceived Accountability
Description
Change in "Perceptions of Accountability" subscale of the Supportive Accountability Scale. The measure used was a 10-item scale on which participants rated the extent to which they agreed with statements on a 7-point likert scale. A total score was generated by summing scores from individual items. Total scores ranged from 10-70 with higher scorings indicating higher perceived accountability. The outcome measure reported here is the change in total score on this measure (decrease) across Phase II where a negative score reflects a decrease in perceived accountability.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan L Butryn, Ph.D.
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33098278
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.
Results Reference
derived
PubMed Identifier
32491152
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.
Results Reference
derived
Learn more about this trial
FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability
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