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| ID | Type | Description | Link |
|---|---|---|---|
| P01AT005013 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.
The high prevalence of obesity and its medical consequences make it one of the most important public health issues in the United States today. Few interventions have been consistently successful at reducing obesity. This trial will test an intervention program that lasts 22 weeks, with 16 evening sessions and one weekend day. Participants will be randomized to one of two arms. Both arms will receive diet and exercise intervention elements. The study aims for gradual weight loss, with a calorie target that will maintain ideal body weight, rather than a more calorie restricted diet. The exercise component is based around increasing walking. The arms will compare methods for producing long-lasting behavior change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHINE A | Experimental | Mindfulness training added to diet-exercise education. |
|
| SHINE B | Active Comparator | Diet-exercise education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHINE | Behavioral | Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detailed nutritional education. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline to 18 Months | weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fat Distribution | change in waist circumference from baseline to 18 mos | 0, 18 mo |
| Insulin Sensitivity | change in HOMA from baseline to 18 months. HOMA-IR is a validated assessment of insulin resistance. HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Hecht, MD | University of California, San Francisco | Principal Investigator |
| Elissa Epel, PhD | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34544560 | Derived | Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005. | |
| 33214537 | Derived | Daubenmier J, Chao MT, Hartogensis W, Liu R, Moran PJ, Acree MC, Kristeller J, Epel ES, Hecht FM. Exploratory Analysis of Racial/Ethnic and Educational Differences in a Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):503-514. doi: 10.1097/PSY.0000000000000859. |
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We recruited participants for a weight loss study comparing two programs involving diet, exercise, and stress management from the community using fliers, newspaper advertisements, online postings, and referrals at UCSF clinics. Participants were enrolled in 6 rounds from July 2009-February 2012. Assessments were completed in October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | SHINE A | SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. |
| FG001 | SHINE B | SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We randomized 194 participants to two arms (100 to group A, 94 to group B).
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| ID | Title | Description |
|---|---|---|
| BG000 | SHINE A | SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight From Baseline to 18 Months | weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data | Two women in Arm B had weight-related variables censored at 18 months due to pregnancy. | Posted | Mean | Standard Deviation | kg | 18 months |
|
Approximately 18 months per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SHINE A | SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rick Hecht, MD | UCSF Osher Center for Integrative Medicine | 4153739743 | rick.hecht@ucsf.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 18 mo |
| Change in Perceived Stress From Baseline to 18 Months | Change in Perceived Stress Scale scores from baseline to 18 months (i.e. approximately one year post-intervention completion), using intention-to-treat. Scores range from 0-40, with higher scores indicating higher perceived stress (worse outcome). | 18 mo |
| Change in Positive Emotions Subscale of the Differential Emotions Scale | We used the 10-item positive emotions subscale of the Differential Emotions Scale (DES; Izard et al., 1991) to assess the extent to which a participant experienced positive emotions in the prior week. Participants responded on a five-point scale (0 = not at all, 4 = extremely; total score possible range 0-40). We summed items to create a total score, with higher scores indicating more positive emotions. | 18 months |
| Stress Hormones | 0, 6, 12 mo |
| Autonomic Nervous System Function | 0, 3,6,12 months |
| Adipocyte Activity | 0, 6 mo |
| Influenza Vaccine Response | 3 months |
| 31724424 | Derived | Radin RM, Epel ES, Daubenmier J, Moran P, Schleicher S, Kristeller J, Hecht FM, Mason AE. Do stress eating or compulsive eating influence metabolic health in a mindfulness-based weight loss intervention? Health Psychol. 2020 Feb;39(2):147-158. doi: 10.1037/hea0000807. Epub 2019 Nov 14. |
| 29901486 | Derived | Mason AE, Hecht FM, Daubenmier JJ, Sbarra DA, Lin J, Moran PJ, Schleicher SG, Acree M, Prather AA, Epel ES. Weight Loss Maintenance and Cellular Aging in the Supporting Health Through Nutrition and Exercise Study. Psychosom Med. 2018 Sep;80(7):609-619. doi: 10.1097/PSY.0000000000000616. |
| 29842903 | Derived | Hecht FM, Moskowitz JT, Moran P, Epel ES, Bacchetti P, Acree M, Kemeny ME, Mendes WB, Duncan LG, Weng H, Levy JA, Deeks SG, Folkman S. A randomized, controlled trial of mindfulness-based stress reduction in HIV infection. Brain Behav Immun. 2018 Oct;73:331-339. doi: 10.1016/j.bbi.2018.05.017. Epub 2018 May 26. |
| 26955895 | Derived | Daubenmier J, Moran PJ, Kristeller J, Acree M, Bacchetti P, Kemeny ME, Dallman M, Lustig RH, Grunfeld C, Nixon DF, Milush JM, Goldman V, Laraia B, Laugero KD, Woodhouse L, Epel ES, Hecht FM. Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial. Obesity (Silver Spring). 2016 Apr;24(4):794-804. doi: 10.1002/oby.21396. Epub 2016 Mar 9. |
| 26867697 | Derived | Mason AE, Epel ES, Aschbacher K, Lustig RH, Acree M, Kristeller J, Cohn M, Dallman M, Moran PJ, Bacchetti P, Laraia B, Hecht FM, Daubenmier J. Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial. Appetite. 2016 May 1;100:86-93. doi: 10.1016/j.appet.2016.02.009. Epub 2016 Feb 8. |
| SHINE B |
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Education | Number | participants with bachelor's degree |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education.
|
|
| Secondary | Fat Distribution | change in waist circumference from baseline to 18 mos | Two women in Arm B had weight-related variables censored at 18 months due to pregnancy. | Posted | Mean | Standard Deviation | cm | 0, 18 mo |
|
|
|
| Secondary | Insulin Sensitivity | change in HOMA from baseline to 18 months. HOMA-IR is a validated assessment of insulin resistance. HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. | 2 participants in Arm A and 1 participant in Arm B did not have the lab results needed to calculate HOMA-IR at 18 months. | Posted | Mean | Standard Error | units on a scale | 18 mo |
|
|
|
| Secondary | Change in Perceived Stress From Baseline to 18 Months | Change in Perceived Stress Scale scores from baseline to 18 months (i.e. approximately one year post-intervention completion), using intention-to-treat. Scores range from 0-40, with higher scores indicating higher perceived stress (worse outcome). | 8 participants in Arm A and 3 in Arm B did not complete this self-report survey at 18 months. | Posted | Mean | Standard Error | units on a scale | 18 mo |
|
|
|
| Secondary | Change in Positive Emotions Subscale of the Differential Emotions Scale | We used the 10-item positive emotions subscale of the Differential Emotions Scale (DES; Izard et al., 1991) to assess the extent to which a participant experienced positive emotions in the prior week. Participants responded on a five-point scale (0 = not at all, 4 = extremely; total score possible range 0-40). We summed items to create a total score, with higher scores indicating more positive emotions. | 8 participants in Arm A and 3 in Arm B did not complete this self-report survey at 18 months. | Posted | Mean | Standard Error | score on a scale | 18 months |
|
|
|
| Secondary | Stress Hormones | Not Posted | 0, 6, 12 mo | Participants |
| Secondary | Autonomic Nervous System Function | Not Posted | 0, 3,6,12 months | Participants |
| Secondary | Adipocyte Activity | Not Posted | 0, 6 mo | Participants |
| Secondary | Influenza Vaccine Response | Not Posted | 3 months | Participants |
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | SHINE B | SHINE: Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. | 0 | 94 | 0 | 94 | 0 | 94 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |