An interventional study of Gold Standard Behavior Therapy for Weight Loss and Standard Remote Behavior Therapy for Weight Loss in Obesity, Overweight and Overweight and Obesity, sponsored by Drexel University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Drexel University · Not applicable, Interventional, and Treatment
Among 23 studies in Obesity by Drexel University — 1 open to participants now, 3 under way, none of them phase 3. Obesity · Drexel University.
Among the 23 studies in Obesity by Drexel University, this one is the 11th largest by enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2017, is one of 23 with no phase, and was the 9th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →1 of the 23 studies in Obesity by Drexel University is open now, in 1 country. Recruiting first, the newest first:
Drexel University · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2017.
This study's enrollment of 87 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 84 across the 22 interventional studies. Of the 19 that completed or were terminated, 5 (26%) have results posted.
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Drexel University is the lead sponsor of 113 studies on the registry; 17 are open to participants now.
2 of the studies in Obesity by Drexel University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06972381Drexel UniversityPiloting a Patient Navigator Program for Weight Loss | 2027-02-15 |
| NCT05408494Drexel UniversityEngaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program | 2027-03-01 |
Among the 23 studies in Obesity by Drexel University, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report.
Behavioral: Gold Standard Behavior Therapy for Weight Loss · Behavioral: Standard Remote Behavior Therapy for Weight Loss
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.
Behavioral: Gold Standard Behavior Therapy for Weight Loss · Behavioral: Digital Data Sharing 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.
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.
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
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
Number of Participants Retained
Feasibility and acceptability metric of retention.
Time frame: 26, 52 weeks
Number of Completed Treatment Contacts
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
Time frame: 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.
Time frame: 52 weeks
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
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
| Milestone | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| Started | 87 | 0 |
| Completed | 77 | 0 |
| Not completed | 10 | 0 |
| Withdrew: Withdrawal by subject | 10 | 0 |
| Milestone | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| Started | 38 | 39 |
| 26 week assessment | 34 | 37 |
| Completed | 33 | 36 |
| Not completed | 5 | 3 |
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.
| kg | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| 13 weeks | -5.78 ± 4.79 | -5.80 ± 4.01 |
| 26 weeks | -1.76 ± 2.81 | -1.54 ± 2.83 |
| 52 weeks | 1.98 ± 3.22 | 0.06 ± 4.16 |
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
| min per week of bouted MVPA | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| 13 weeks | 173.62 ± 137.16 | 125.86 ± 134.16 |
| 52 weeks | 94.15 ± 99.39 | 101.68 ± 98.16 |
Feasibility and acceptability metric of retention.
| Participants | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| 26 weeks | 34 | 37 |
| 52 weeks | 33 | 36 |
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
| number completed | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| Phone Calls | 7.37 ± 1.55 | 7.20 ± 1.79 |
| Text Messages | 30.50 ± 3.85 | 29.67 ± 5.94 |
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.
| score | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| Treatment Acceptability Questionnaire (TAQ) | 65.62 ± 8.43 | 65.95 ± 7.76 |
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.
| percent days self-monitoring occurred | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| Weight | 43 | 58 |
| Eating | 41 | 67 |
| Physical Activity | 79 | 80 |
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.
| unit change | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| Perceived Accountability | 8.28 ± 15.25 | 6.88 ± 16.05 |
Collected over 52 weeks (entire study period). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lifestyle Modification | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Lifestyle Modification + Share | 0/39 (0%) | 0/39 (0%) | 3/39 (7.7%) |
| Event | Lifestyle Modification | Lifestyle Modification + Share |
|---|---|---|
| GallstonesGastrointestinal disorders | 0/38 | 1/39 |
| LightheadednessVascular disorders | 0/38 | 1/39 |
| Kidney StoneRenal and urinary disorders | 0/38 | 1/39 |
| Age, Continuous(years) | Lifestyle Modification | Lifestyle Modification + Share | Total |
|---|---|---|---|
| Mean | 51.71 ± 13.33 | 49.84 ± 13.56 | 50.77 ± 13.39 |
| Sex: Female, Male(Participants) | Lifestyle Modification | Lifestyle Modification + Share | Total |
|---|---|---|---|
| Female | 30 | 32 | 62 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Lifestyle Modification | Lifestyle Modification + Share | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 36 | 38 | 74 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lifestyle Modification | Lifestyle Modification + Share | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 15 | 28 |
| White | 19 | 22 | 41 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Lifestyle Modification | Lifestyle Modification + Share | Total |
|---|---|---|---|
| United States | 38 | 39 | 77 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in May 2019, 18 months.
Results were first posted in Jan 2021, 1 year 7 months after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 18 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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