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| ID | Type | Description | Link |
|---|---|---|---|
| K12HD052023 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.
The proposed pilot project seeks to enhance motivation for lifestyle change in adolescents who are obese. It will test a novel intervention that combines modified MI-based counseling and BDS. We will test the feasibility of the intervention over a 12-week period, with 24-week follow-up compared to use of standard digital scale. All participants will undergo the standard adolescent weight loss program, which includes monthly clinic visits with dietary and physical activity counseling. The MI intervention will include modified MI, brief weekly telephone reinforcement, and use of a BDS. The BDS with its mobile app offers daily feedback through colors, daily missions to promote healthy habits, and weekly healthy tips from nutritionists. In addition to the primary outcome of feasibility (daily weighing) investigators will also explore the intervention's effect on motivation, psychological outcomes and various aspects of feasibility and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Numberless BDS and Modified-MI | Experimental | Use of numberless BDS (color coded), app, and motivational interviewing. Participants will weigh daily and receive weekly motivational interviewing at clinic visits and via a weekly phone call. |
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| Digital Scale | Active Comparator | Use standard digital scale (number readout). Participants will weigh daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Numberless BDS | Behavioral | Participants perform daily weighing using a numberless BDS with feedback from app (color codes, challenges), in conjunction with modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Modified MI and BDS | Attendance at in-clinic visits, completion of weekly phone calls, and daily weighing based on BDS app data collected at 24 week assessment. | 24 weeks |
| Acceptability of Modified MI and BDS | Number of participants in each group who are lost to follow-up | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometrics | Body Mass Index (BMI) | 24 weeks |
| Bio-impedence measures | Measures body fat (%) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Age 19 years or older
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| Name | Affiliation | Role |
|---|---|---|
| Kanika Bowen-Jallow, MD, MMS | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTMB | League City | Texas | 77573 | United States | ||
| UTMB |
The investigators will provide access to all data, regardless of publication, collected on this project. All external investigators must supply a written request identifying their research questions (s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data would be stored and who would have access.
Data available upon request
All external investigators must supply a written request identifying their research questions (s) and specifying the data they would like to analyze. The request must include a data security plan and explanation of how the data would be stored and who would have access.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Digital Scale | Behavioral | Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program |
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| Modified Motivational Interviewing | Behavioral | Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program. |
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| Anxiety | Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory | Change from 0 to 24 weeks |
| Depression | Self-reported depression screening on a scale from 0 (not at all) to 3 (nearly every day) using the PHQ-9: Modified for Teens | Change from 0 to 24 weeks |
| Bio-impedence measures | Measures muscle mass (%) | 24 weeks |
| Bio-impedence measures | Measures visceral fat (%) | 24 weeks |
| Webster |
| Texas |
| 77598 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |