ClinicalTrials.gg
CompletedNCT03387709Updated Mar 24, 2020

UCSD Get Fit, Be Fit Study

An interventional study of Pistachio-enriched diet and General dietary guidance diet in Overweight and Obesity, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Obesity by University of California, San Diego — 3 open to participants now, 8 under way, none of them phase 3. Obesity · University of California, San Diego.

Enrollment
26th of 51
100 · median 100
Started
2018
with 4 others
No phase
46 of 59
2 open now
Registered
39th of 59
by date

Among the 59 studies in Obesity by University of California, San Diego, this one is the 26th largest by enrollment of the 51 interventional ones that give a count, is one of 5 that started in 2018, is one of 46 with no phase, and was the 39th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

3 of the 59 studies in Obesity by University of California, San Diego are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 21 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 59 studies in Obesity by University of California, San Diego, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Overweight and Obesity

Browse trials for

Keywords

  • Nondiabetic
  • Overweight
  • Obesity
  • Men
  • Women
  • San Diego
  • Weight Loss
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 100 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and Women who reside in the San Diego area
  • Age 21 and older
  • ≥ 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

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
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralPistachio-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.

  • BehavioralGeneral 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.

07

What researchers measure

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.

    Time frame: 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.

    Time frame: 4 months

Other outcomes

  1. Dietary intake and food choices

    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

08

Study locations

1 site
  • University of California, San Diego
    La Jolla, California 92093, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jul 2019, 15 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 15 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2017
First posted
Jan 2, 2018
StartActual
Apr 4, 2018
Primary completionActual
Jul 31, 2019
CompletionActual
Oct 31, 2019
Last update
Mar 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03387709
Collaborators
American Pistachio Growers
Responsible party
Cheryl Rock (Principal Investigator, University of California, San Diego) — Principal investigator
First posted
Jan 2, 2018
Start date
Apr 4, 2018
Primary completion
Jul 31, 2019
Completion
Oct 31, 2019
Last update
Mar 24, 2020

Study contacts

Cheryl L Rock, PhD, RD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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