Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

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

Detailed Description
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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.

Official Title
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Supporting Health by Integrating Nutrition and Exercise (SHINE)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: SHINE


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHINE A<br> | Behavioral: SHINE<br>* 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.<br>|
| Active Comparator: SHINE B<br> | Behavioral: SHINE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss and maintenance of weight loss |  | 0,3,6,12,18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat distribution |  | 0, 6 mo | 
| insulin sensitivity |  | 0, 3,6,12,18 mo | 
| perceived stress |  | 0, 3,6,12,18 mo | 
| mood |  | 0, 3,6,12,18 mo | 
| stress hormones |  | 0, 6, 12 mo | 
| autonomic nervous system function |  | 0, 3,6,12 | 
| adipocyte activity |  | 0, 6 mo | 
| influenza vaccine response |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, randomized controlled trial, weight loss, metabolic syndrome