Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: SHINE

• Registration Number: NCT00960414
• Lead Sponsor: University of California, San Francisco

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-17
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2021-03-17
• Results First Submitted QC: 2024-01-19
• Results First Posted: 2024-02-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHINE B	SHINE	Diet-exercise education.
SHINE A	SHINE	Mindfulness training added to diet-exercise education.

Primary Outcome Measures

Name	Time	Method
Change in Weight From Baseline to 18 Months	18 months	weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data

Secondary Outcome Measures

Name	Time	Method
Autonomic Nervous System Function	0, 3,6,12 months
Influenza Vaccine Response	3 months
Insulin Sensitivity	18 mo	change in HOMA from baseline to 18 months. HOMA-IR is a validated assessment of insulin resistance. HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Change in Positive Emotions Subscale of the Differential Emotions Scale	18 months	We used the 10-item positive emotions subscale of the Differential Emotions Scale (DES; Izard et al., 1991) to assess the extent to which a participant experienced positive emotions in the prior week. Participants responded on a five-point scale (0 = not at all, 4; = extremely; total score possible range 0-40). We summed items to create a total score, with higher scores indicating more positive emotions.
Stress Hormones	0, 6, 12 mo
Adipocyte Activity	0, 6 mo
Fat Distribution	0, 18 mo	change in waist circumference from baseline to 18 mos
Change in Perceived Stress From Baseline to 18 Months	18 mo	Change in Perceived Stress Scale scores from baseline to 18 months (i.e. approximately one year post-intervention completion), using intention-to-treat. Scores range from 0-40, with higher scores indicating higher perceived stress (worse outcome).

Trial Locations

Locations (1)

Osher Center for Integrative Medicine; 🇺🇸 San Francisco, California, United States