UCSD Get Fit, Be Fit Study

NCT03387709 | Completed

• 1 other identifier: 172109
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (1)

• Metabolic and cardiovascular disease risk

  4 months

Other Outcomes (1)

• Dietary intake and food choices

  4 months

Study Arms (2)

Pistachio-enriched diet

EXPERIMENTAL

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

General dietary guidance diet

ACTIVE COMPARATOR

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

Behavioral: General dietary guidance diet

Interventions

Pistachio-enriched diet BEHAVIORAL

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.

Pistachio-enriched diet

General dietary guidance diet BEHAVIORAL

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.

General dietary guidance diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• American Pistachio Growers: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Multiple Endocrine Neoplasia Type 1; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Body Weight Changes

Study Officials

• Cheryl L Rock, PhD, RD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 2, 2018
• Study Start: April 4, 2018
• Primary Completion: July 31, 2019
• Study Completion: October 31, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)