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UCSD Get Fit, Be Fit Study

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ClinicalTrials.gov Identifier: NCT03387709
Recruitment Status : Active, not recruiting
First Posted : January 2, 2018
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
American Pistachio Growers
Information provided by (Responsible Party):
Cheryl Rock, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE January 2, 2018
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE April 4, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03387709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE UCSD Get Fit, Be Fit Study
Official Title  ICMJE Effects of Pistachio Consumption in a Weight Loss Intervention on Weight Change, Dietary Intake and Metabolic Factors
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Pistachio-enriched diet
  • Active Comparator: General dietary guidance diet
    Participants in this group will receive general dietary guidance as part of a 4-month long group intervention.
    Intervention: Behavioral: General dietary guidance diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03387709
Other Study ID Numbers  ICMJE 172109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cheryl Rock, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE American Pistachio Growers
Investigators  ICMJE
Principal Investigator: Cheryl L Rock, PhD, RD University of California, San Diego
PRS Account University of California, San Diego
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP