UCSD Get Fit, Be Fit Study
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|ClinicalTrials.gov Identifier: NCT03387709|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Pistachio-enriched diet Behavioral: General dietary guidance diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Pistachio Consumption in a Weight Loss Intervention on Weight Change, Dietary Intake and Metabolic Factors|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Pistachio-enriched diet
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
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.
Active Comparator: General dietary guidance diet
Participants in this group will receive general dietary guidance as part of a 4-month long group intervention.
Behavioral: General dietary guidance diet
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.
- Weight Loss [ Time Frame: 4 months ]Weight loss after a 4-month cognitive-behavioral intervention among the pistachio enriched diet arm as compared to general dietary guidance study arm.
- Metabolic and cardiovascular disease risk [ Time Frame: 4 months ]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.
- Dietary intake and food choices [ Time Frame: 4 months ]The differential response in dietary intake and food choices in association with prescribing the pistachio-enriched diet as compared to general dietary guidance at 2-months and 4-months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387709
|Contact: Elizabeth Quintana, MS, RDfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Elizabeth Quintana, MS, RDN 858-822-6162 email@example.com|
|Principal Investigator:||Cheryl L Rock, PhD, RD||University of California, San Diego|