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Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons (SHINE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00960414
First received: August 13, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Obesity
Behavioral: SHINE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supporting Health by Integrating Nutrition and Exercise (SHINE)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • weight loss and maintenance of weight loss [ Time Frame: 0,3,6,12,18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fat distribution [ Time Frame: 0, 6 mo ] [ Designated as safety issue: No ]
  • insulin sensitivity [ Time Frame: 0, 3,6,12,18 mo ] [ Designated as safety issue: No ]
  • perceived stress [ Time Frame: 0, 3,6,12,18 mo ] [ Designated as safety issue: No ]
  • mood [ Time Frame: 0, 3,6,12,18 mo ] [ Designated as safety issue: No ]
  • stress hormones [ Time Frame: 0, 6, 12 mo ] [ Designated as safety issue: No ]
  • autonomic nervous system function [ Time Frame: 0, 3,6,12 ] [ Designated as safety issue: No ]
  • adipocyte activity [ Time Frame: 0, 6 mo ] [ Designated as safety issue: No ]
  • influenza vaccine response [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: August 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHINE A Behavioral: 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.
Active Comparator: SHINE B Behavioral: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960414

Locations
United States, California
Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Frederick Hecht, MD University of California, San Francisco
Study Chair: Elissa Epel, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00960414     History of Changes
Other Study ID Numbers: P01 AT005013, P01AT005013, NIH P01 AT005013
Study First Received: August 13, 2009
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
obesity
randomized controlled trial
weight loss
metabolic syndrome

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014