Clinical trial NCT00960414: Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons
Official title: Supporting Health by Integrating Nutrition and Exercise (SHINE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
randomized controlled trial
weight loss
metabolic syndrome
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-08-17
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18+ years old
* BMI \> 30-45
* Waist circumference \> 102 cm (men) or \> 88 cm (women)
* Live in San Francisco Bay Area and able to attend more than 16 classes and up to 12 assessment visits in San Francisco over an 18 month period

Exclusion Criteria:

* Inability to provide informed consent
* Age \< 18
* A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the group intervention
* Type I or II Diabetes or fasting glucose ≥ 126 mg/dl or hemoglobin A1c ≥ 6.5; those with HbA1c between 6-6.5% may complete an OGTT to rule out diabetes (glucose \<200 mg/dl)
* Use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications
* Use of immunosuppressive or immunomodulating drugs or chronic or acute conditions that would require the use of such medications
* A history of known coronary artery disease (CAD), or typical or atypical anginal chest pain requires a letter from the participant's physician that he or she has been adequately evaluated and that a moderate exercise program is appropriate
* Non English speaker
* Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum
* Initiation of new class of psychiatric medications in past 2 months
* Currently on a specific weight loss diet
* For influenza vaccine administration: a prior allergic reaction to the influenza vaccine or eggs. These participants can be included in the trial but will be excluded from participation in influenza vaccination.
* Active bulimia or strong history of bulimia
* Current use of weight loss medications or supplements such as amphetamine-based drugs that are believed to have some effect on weight
* History of or planned weight loss surgery
* Untreated hypothyroidism: TSH \> 4mU/mL (or the upper limit of normal reference defined by the lab doing the assay)

Primary outcomes:
measure: Change in Weight From Baseline to 18 Months
timeFrame: 18 months
Secondary outcomes:
measure: Fat Distribution
timeFrame: 0, 18 mo
measure: Insulin Sensitivity
timeFrame: 18 mo
measure: Change in Perceived Stress From Baseline to 18 Months
timeFrame: 18 mo
measure: Change in Positive Emotions Subscale of the Differential Emotions Scale
timeFrame: 18 months
measure: Stress Hormones
timeFrame: 0, 6, 12 mo
measure: Autonomic Nervous System Function
timeFrame: 0, 3,6,12 months
measure: Adipocyte Activity
timeFrame: 0, 6 mo
measure: Influenza Vaccine Response
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Frederick Hecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elissa Epel, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.