Status:
COMPLETED
UCSD Get Fit, Be Fit Study
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
American Pistachio Growers
Conditions:
Overweight and Obesity
Eligibility:
All Genders
21+ years
Phase:
NA
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 wome...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03387709
Start Date
April 4 2018
End Date
October 31 2019
Last Update
March 24 2020
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92093