Obesity, Overweight, Overweight and Obesity, Weight Loss
Conditions
Keywords
Weight Loss, Obesity, Overweight, Behavioral Weight Loss
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.
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.
BEHAVIORALStandard 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.
BEHAVIORALDigital 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Behavioral and Social Sciences Research (OBSSR)
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity | 13, 52 weeks | Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA). |
| Number of Completed Treatment Contacts | 52 weeks | Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages). |
| Treatment Acceptability Questionnaire (TAQ) | 52 weeks | 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. |
| Change in Body Weight | 0, 13, 26, 52 weeks | 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. |
| Number of Participants Retained | 26, 52 weeks | Feasibility and acceptability metric of retention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Accountability | 52 weeks | 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. |
| Self-monitoring Engagement | 13-52 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 38 |
| 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.
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.
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. | 39 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase I | Withdrawal by Subject | 10 | 0 |
Baseline characteristics
| Characteristic | Lifestyle Modification | Total | Lifestyle Modification + Share |
|---|---|---|---|
| Age, Continuous | 51.71 years STANDARD_DEVIATION 13.33 | 50.77 years STANDARD_DEVIATION 13.39 | 49.84 years STANDARD_DEVIATION 13.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 74 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 28 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 41 Participants | 22 Participants |
| Region of Enrollment United States | 38 participants | 77 participants | 39 participants |
| Sex: Female, Male Female | 30 Participants | 62 Participants | 32 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 0 / 38 | 3 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
Primary
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.
Time frame: 0, 13, 26, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Modification | Change in Body Weight | 13 weeks | -5.78 kg | Standard Deviation 4.79 |
| Lifestyle Modification | Change in Body Weight | 26 weeks | -1.76 kg | Standard Deviation 2.81 |
| Lifestyle Modification | Change in Body Weight | 52 weeks | 1.98 kg | Standard Deviation 3.22 |
| Lifestyle Modification + Share | Change in Body Weight | 13 weeks | -5.80 kg | Standard Deviation 4.01 |
| Lifestyle Modification + Share | Change in Body Weight | 26 weeks | -1.54 kg | Standard Deviation 2.83 |
| Lifestyle Modification + Share | Change in Body Weight | 52 weeks | 0.06 kg | Standard Deviation 4.16 |
Comparison: Comparing groups on 13 week weight loss, prior to randomization.p-value: 0.98ANCOVA
Comparison: Comparing groups on 26 week weight lossp-value: 0.75ANCOVA
Comparison: Comparing groups on 52 week weight lossp-value: 0.02ANCOVA
Primary
Change in Physical Activity
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
Time frame: 13, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Modification | Change in Physical Activity | 13 weeks | 173.62 min per week of bouted MVPA | Standard Deviation 137.16 |
| Lifestyle Modification | Change in Physical Activity | 52 weeks | 94.15 min per week of bouted MVPA | Standard Deviation 99.39 |
| Lifestyle Modification + Share | Change in Physical Activity | 13 weeks | 125.86 min per week of bouted MVPA | Standard Deviation 134.16 |
| Lifestyle Modification + Share | Change in Physical Activity | 52 weeks | 101.68 min per week of bouted MVPA | Standard Deviation 98.16 |
Comparison: Comparing groups on 13 week MVPAp-value: 0.12ANCOVA
Comparison: Comparing groups on 52 week MVPAp-value: 0.16ANCOVA
Primary
Number of Completed Treatment Contacts
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
Time frame: 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Modification | Number of Completed Treatment Contacts | Phone Calls | 7.37 number completed | Standard Deviation 1.55 |
| Lifestyle Modification | Number of Completed Treatment Contacts | Text Messages | 30.50 number completed | Standard Deviation 3.85 |
| Lifestyle Modification + Share | Number of Completed Treatment Contacts | Phone Calls | 7.20 number completed | Standard Deviation 1.79 |
| Lifestyle Modification + Share | Number of Completed Treatment Contacts | Text Messages | 29.67 number completed | Standard Deviation 5.94 |
Comparison: Comparing groups on phone calls completed in Phase II (52 weeks)p-value: 0.64Permutation test
Comparison: Comparing groups on text messages completed in Phase II (52 weeks)p-value: 0.499Permutation test
Primary
Number of Participants Retained
Feasibility and acceptability metric of retention.
Time frame: 26, 52 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Modification | Number of Participants Retained | 26 weeks | 34 Participants |
| Lifestyle Modification | Number of Participants Retained | 52 weeks | 33 Participants |
| Lifestyle Modification + Share | Number of Participants Retained | 52 weeks | 36 Participants |
| Lifestyle Modification + Share | Number of Participants Retained | 26 weeks | 37 Participants |
Comparison: Comparing groups on 26 week retention ratesp-value: 0.43Fisher Exact
Comparison: Comparing groups on 52 week retention rates.p-value: 0.48Fisher Exact
Primary
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Modification | Treatment Acceptability Questionnaire (TAQ) | 65.62 score | Standard Deviation 8.43 |
| Lifestyle Modification + Share | Treatment Acceptability Questionnaire (TAQ) | 65.95 score | Standard Deviation 7.76 |
Comparison: Comparing groups on TAQ scores at 52 weeksp-value: 0.86Permutation test
Secondary
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Modification | Perceived Accountability | 8.28 unit change | Standard Deviation 15.25 |
| Lifestyle Modification + Share | Perceived Accountability | 6.88 unit change | Standard Deviation 16.05 |
Comparison: Comparing groups on changes in perceived accountability during Phase IIp-value: 0.005ANCOVA
Secondary
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.
Time frame: 13-52 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lifestyle Modification | Self-monitoring Engagement | Weight | 43 percent days self-monitoring occurred |
| Lifestyle Modification | Self-monitoring Engagement | Eating | 41 percent days self-monitoring occurred |
| Lifestyle Modification | Self-monitoring Engagement | Physical Activity | 79 percent days self-monitoring occurred |
| Lifestyle Modification + Share | Self-monitoring Engagement | Weight | 58 percent days self-monitoring occurred |
| Lifestyle Modification + Share | Self-monitoring Engagement | Eating | 67 percent days self-monitoring occurred |
| Lifestyle Modification + Share | Self-monitoring Engagement | Physical Activity | 80 percent days self-monitoring occurred |
Comparison: Comparing groups on percent days of self-monitoring of weight during Phase IIp-value: 0.002ANCOVA
Comparison: Comparing groups on percent days of self-monitoring of eating during Phase IIp-value: 0.001ANCOVA
Comparison: Comparing groups on percent days of self-monitoring of physical activity during Phase IIp-value: 0.25ANCOVA