Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

NCT00960414 | Completed Results DMC

• 1 other identifier: P01AT005013
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

obesity; randomized controlled trial; weight loss; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Fat Distribution

  0, 18 mo

• Insulin Sensitivity

  18 mo

• Change in Perceived Stress From Baseline to 18 Months

  18 mo

• Change in Positive Emotions Subscale of the Differential Emotions Scale

  18 months

• Stress Hormones

  0, 6, 12 mo

Study Arms (2)

SHINE A

EXPERIMENTAL

Mindfulness training added to diet-exercise education.

Behavioral: SHINE

SHINE B

ACTIVE COMPARATOR

Diet-exercise education.

Behavioral: SHINE

Interventions

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.

SHINE A; SHINE B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

Related Publications (7)

• 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.

  PMID: 34544560 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.

  PMID: 33214537 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.

  PMID: 31724424 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.

  PMID: 29901486 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.

  PMID: 29842903 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.

  PMID: 26955895 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.

  PMID: 26867697 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Results Point of Contact

• Title: Rick Hecht, MD
• Organization: UCSF Osher Center for Integrative Medicine

rick.hecht@ucsf.edu

4153739743

Study Officials

• Frederick Hecht, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Elissa Epel, PhD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 24, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-07

Locations

US (1)