Overweight and ObesityNCT03387709
UCSD Get Fit, Be Fit Study
A study testing Pistachio-enriched diet and General dietary guidance diet in people with Overweight and Obesity, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Pistachio-enriched diet and General dietary guidance diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Effects of Pistachio Consumption in a Weight Loss Intervention on Weight Change, Dietary Intake and Metabolic Factors
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Pistachio-enriched diet, General dietary guidance diet
- Keywords
- Nondiabetic, Overweight, Obesity, Men, Women, San Diego, Weight Loss
- Medical subject headings
- Overweight, Obesity, Multiple Endocrine Neoplasia Type 1, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pistachio-enriched dietBehavioural
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.
General dietary guidance dietBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General dietary guidance diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start4 Apr 2018
- Primary completion31 Jul 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American Pistachio Growers
- Responsible party
- Principal investigator, Cheryl Rock, University of California, San Diego
- Investigators
- Cheryl L Rock, PhD, RD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387709
- Sponsor's protocol ID
- 172109
- Status last verified
- Mar 2020
- First submitted
- 18 Dec 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pistachio Consumption in a Weight Loss Intervention on Weight Change, Dietary Intake and Metabolic Factors
- ClinicalTrials.gov ID
- NCT03387709
- Acronym / sponsor ID
- 172109
- Conditions
- Overweight and Obesity
- Keywords
- Nondiabetic, Overweight, Obesity, Men, Women, San Diego, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American Pistachio Growers
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pistachio-enriched diet | Experimental | Behavioral: Pistachio-enriched dietParticipants 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. |
| General dietary guidance diet | Active comparator | Behavioral: General dietary guidance dietParticipants in this group will receive general dietary guidance as part of a 4-month long group intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pistachio-enriched dietComposition 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. | Behavioural | Pistachio-enriched diet |
| General dietary guidance dietDuring 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. | Behavioural | General dietary guidance diet |
Primary outcome
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.
1 secondary outcome
Metabolic and cardiovascular disease risk
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl L Rock, PhD, RD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachio-enriched diet and General dietary guidance diet in people with Overweight and Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.