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| ID | Type | Description | Link |
|---|---|---|---|
| P01NR010949 | U.S. NIH Grant/Contract | View source |
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This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.
Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:
Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.
Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Standard Behavioral Treatment (SBT) | Active Comparator | This group receives standard behavioral treatment for weight loss as described below. |
|
| 2: Modified SBT + Self-Efficacy | Experimental | This group receives modified SBT with an additional self-efficacy component as described below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Behavioral Treatment | Behavioral | SBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 12 and 18 months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | 12 and 18 months post enrollment | |
| Adherence to treatment protocol | 12 and 18 months post enrollment |
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Inclusion Criteria:
NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lora E. Burke, PhD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Nursing | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30314417 | Derived | Imes CC, Zheng Y, Mendez DD, Rockette-Wagner BJ, Mattos MK, Goode RW, Sereika SM, Burke LE. Group-Based Trajectory Analysis of Physical Activity Change in a US Weight Loss Intervention. J Phys Act Health. 2018 Nov 1;15(11):840-846. doi: 10.1123/jpah.2017-0484. Epub 2018 Oct 12. | |
| 26727241 | Derived | Zheng Y, Sereika SM, Ewing LJ, Danford CA, Terry MA, Burke LE. Association between Self-Weighing and Percent Weight Change: Mediation Effects of Adherence to Energy Intake and Expenditure Goals. J Acad Nutr Diet. 2016 Apr;116(4):660-6. doi: 10.1016/j.jand.2015.10.014. Epub 2015 Dec 25. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Modified Standard Behavioral Intervention + Self-Efficacy | Behavioral | This group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling. |
|
| 26609668 | Derived | Goode RW, Ye L, Sereika SM, Zheng Y, Mattos M, Acharya SD, Ewing LJ, Danford C, Hu L, Imes CC, Chasens E, Osier N, Mancino J, Burke LE. Socio-demographic, anthropometric, and psychosocial predictors of attrition across behavioral weight-loss trials. Eat Behav. 2016 Jan;20:27-33. doi: 10.1016/j.eatbeh.2015.11.009. Epub 2015 Nov 14. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |