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UCSD Get Fit, Be Fit Study

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pistachio-enriched diet

General dietary guidance diet

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Nondiabetic, Overweight, Obesity, Men, Women, San Diego, Weight Loss

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pistachio-enriched diet

General dietary guidance diet

Arm Description

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.

Participants in this group will receive general dietary guidance as part of a 4-month long group intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03387709

First Posted

December 18, 2017

Last Updated

March 23, 2020

Sponsor

University of California, San Diego

Collaborators

American Pistachio Growers

1. Study Identification

Unique Protocol Identification Number

NCT03387709

Brief Title

UCSD Get Fit, Be Fit Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

April 4, 2018 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

American Pistachio Growers

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

Nondiabetic, Overweight, Obesity, Men, Women, San Diego, Weight Loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pistachio-enriched diet

Arm Type

Experimental

Arm Description

Arm Title

General dietary guidance diet

Arm Type

Active Comparator

Arm Description

Participants in this group will receive general dietary guidance as part of a 4-month long group intervention.

Intervention Type

Behavioral

Intervention Name(s)

Pistachio-enriched diet

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

General dietary guidance diet

Intervention Description

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 Measure Information:

Title

Weight Loss

Description

Weight loss after a 4-month cognitive-behavioral intervention among the pistachio enriched diet arm as compared to general dietary guidance study arm.

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Metabolic and cardiovascular disease risk

Description

Time Frame

4 months

Other Pre-specified Outcome Measures:

Title

Dietary intake and food choices

Description

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.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheryl L Rock, PhD, RD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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