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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
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 detailed nutritional education.
Osher Center for Integrative Medicine
San Francisco, California, United States
Change in Weight From Baseline to 18 Months
weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data
Time frame: 18 months
Fat Distribution
change in waist circumference from baseline to 18 mos
Time frame: 0, 18 mo
Insulin Sensitivity
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.
Time frame: 18 mo
Change in Perceived Stress From Baseline to 18 Months
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).
Time frame: 18 mo
Change in Positive Emotions Subscale of the Differential Emotions Scale
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.
Time frame: 18 months
Stress Hormones
Time frame: 0, 6, 12 mo
Autonomic Nervous System Function
Time frame: 0, 3,6,12 months
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Adipocyte Activity
Time frame: 0, 6 mo
Influenza Vaccine Response
Time frame: 3 months