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

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ClinicalTrials.gov Identifier: NCT00960414
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : May 6, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

August 13, 2009
August 17, 2009
May 6, 2014
August 2009
August 2013   (Final data collection date for primary outcome measure)
weight loss and maintenance of weight loss [ Time Frame: 0,3,6,12,18 months ]
Same as current
Complete list of historical versions of study NCT00960414 on ClinicalTrials.gov Archive Site
  • fat distribution [ Time Frame: 0, 6 mo ]
  • insulin sensitivity [ Time Frame: 0, 3,6,12,18 mo ]
  • perceived stress [ Time Frame: 0, 3,6,12,18 mo ]
  • mood [ Time Frame: 0, 3,6,12,18 mo ]
  • stress hormones [ Time Frame: 0, 6, 12 mo ]
  • autonomic nervous system function [ Time Frame: 0, 3,6,12 ]
  • adipocyte activity [ Time Frame: 0, 6 mo ]
  • influenza vaccine response [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons
Supporting Health by Integrating Nutrition and Exercise (SHINE)
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
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.
  • Experimental: SHINE A
    Intervention: Behavioral: SHINE
  • Active Comparator: SHINE B
    Intervention: Behavioral: SHINE

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
200
August 2013
August 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00960414
P01AT005013( U.S. NIH Grant/Contract )
P01AT005013 ( U.S. NIH Grant/Contract )
NIH P01 AT005013
Yes
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Frederick Hecht, MD University of California, San Francisco
Study Chair: Elissa Epel, PhD University of California, San Francisco
University of California, San Francisco
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP