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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
Sponsor:
Collaborator:
American Pistachio Growers
Information provided by (Responsible Party):
Cheryl Rock, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Pistachio-enriched diet Behavioral: General dietary guidance diet Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Elizabeth Quintana, MS, RD 858-822-6162 elquintana@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Elizabeth Quintana, MS, RDN    858-822-6162    elquintana@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
American Pistachio Growers
Investigators
Principal Investigator: Cheryl L Rock, PhD, RD University of California, San Diego

Responsible Party: Cheryl Rock, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03387709     History of Changes
Other Study ID Numbers: 172109
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cheryl Rock, University of California, San Diego:
Nondiabetic
Overweight
Obesity
Men
Women
San Diego
Weight Loss

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms