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Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

Supporting Health by Integrating Nutrition and Exercise (SHINE)

NCT00960414•University of California, San Francisco

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+6 more criteria

Locations (1)

Osher Center for Integrative Medicine

San Francisco, California, United States

Key Dates

Start Date

August 1, 2009

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

July 24, 2024

Enrollment

194

ACTUAL participants

Conditions

Obesity

Interventions

SHINE

BEHAVIORAL

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

Inclusion Criteria

Exclusion Criteria

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