UCSD Get Fit, Be Fit Study

Study Overview
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Brief Summary
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The purpose of the Get Fit, Be Fit Study is to examine the effect of incorporating pistachios in an intensive 4-month cognitive-behavioral weight loss intervention in overweight and obese men and women, to examine effects on metabolic factors, and to monitor and examine changes in dietary intake and food choices during the intervention, in a randomized controlled study.

Detailed Description
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This study investigates whether pistachios help to promote weight loss and improve metabolic and cardiovascular disease risk factors in 100 overweight or obese men and women who are participating in a 4-month behavioral weight loss intervention. Participants will be assigned to a cognitive-behavioral weight loss intervention and will be provided either general dietary advice as a component of the behavioral curriculum or prescribed an individualized pistachio-enriched reduced-energy diet plan. The pistachio-enriched diet will prescribe 42 g/day of pistachios, or approximately 13-20% (averaging 18%) of energy intake across a range of 1200-1800 kcal/day. Dietary intake will be assessed at three time points (baseline, one month, and four months) to examine changes in dietary intake and food choices that may be indicative of compensatory intake in response to regular nut consumption. Results from this study will contribute to understanding the role of pistachios in weight control, including further knowledge of the metabolic factors linked to chronic disease, and will expand knowledge of how pistachios in the diet may contribute to the prevention and management of obesity.

Official Title
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Effects of Pistachio Consumption in a Weight Loss Intervention on Weight Change, Dietary Intake and Metabolic Factors

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Pistachio-enriched diet
* Behavioral: General dietary guidance diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women who reside in the San Diego area Age 21 and older BMI ≥ 27.0 kg/m2 and ≤40 kg/m2 No known allergy to tree nuts Non-diabetic Non-smoker Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals Able to provide data through questionnaires and by telephone Willing to maintain contact with the investigators for 6 months Willing to allow blood collections Capable of performing a simple test for assessing cardiopulmonary fitness Willing and able to be physically active Exclusion Criteria: Inability to participate in physical activity because of severe disability Inability to restrict consumption of nuts for four months History or presence of a co-morbid disease for which diet modification and increased physical activity may be contraindicated Self-reported pregnancy or breastfeeding or planning a pregnancy within the next year Currently actively involved in another diet intervention study or organized weight loss program Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial. Prior to enrollment Subjects will be screened for diabetes and considered ineligible with a fasting blood glucose ≥125 mg/dL.

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pistachio-enriched diet<br>Participants in this group will be individually counseled on a lower calorie diet, receive pistachios to be consumed daily for four months, and receive print materials on incorporating pistachios into their diet. | Behavioral: Pistachio-enriched diet<br>* Composition of prescribed diets will be based on individual preferences, with the goal of consuming 1.5 oz of pistachios per day and increased energy expenditure. During the 4-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Pistachios will be provided to participants. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.<br>|
| Active Comparator: General dietary guidance diet<br>Participants in this group will receive general dietary guidance as part of a 4-month long group intervention. | Behavioral: General dietary guidance diet<br>* During the 4-month group intervention, study subjects will participate group sessions, receive telephone, email and/or text message contacts to provide support and behavioral guidance and strategies. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Weight loss after a 4-month cognitive-behavioral intervention among the pistachio enriched diet arm as compared to general dietary guidance study arm. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic and cardiovascular disease risk | The differential response in metabolic and cardiovascular disease risk factors, including lipids, glucose, insulin and insulin resistance among the pistachio enriched diet arm as compared to general dietary guidance study arm after four months. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nondiabetic, Overweight, Obesity, Men, Women, San Diego, Weight Loss