Status:
COMPLETED
DIETFITS Study (Diet Intervention Examining the Factors Interacting With Treatment Success
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Nutrition Science Initiative
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Genomics research is advancing rapidly, and links between genes and obesity continue to be discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in multiple genes h...
Detailed Description
If the intriguing preliminary retrospective results are confirmed in this full scale study, the results will demonstrate that inexpensive DNA testing could help dieters predict whether they will have ...
Eligibility Criteria
Inclusion
- Age: \> 18 years of age
- Women: Pre-menopausal (self-report) and \<50 years of age
- Men: \<50 years of age
- BMI (body mass index): 27-40 kg/m2 (need to lose \>10% body weight to achieve healthy BMI)
- Body weight stable for the last two months, and not actively on a weight loss plan
- No plans to move from the area over the next two years
- Available and able to participate in the evaluations and intervention for the study period
- Willing to accept random assignment
- To enhance study generalizability, people on medications not noted below as specific exclusions can
- participate if they have been stable on such medications for at least three months
- Ability and willingness to give written informed
- No known active psychiatric illness
Exclusion
- Subjects with the following conditions will be excluded (determined by self-report):
- Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next 2 years
- Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication
- Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction (\<6 months)(patient self-report and, if available, review of labs from primary care provider)
- Smokers (because of effect on weight and lipids)
- History of serious arrhythmias, or cerebrovascular disease
- Uncontrolled hyper- or hypothyroidism (TSH not within normal limits)
- Medications: Lipid lowering, antihypertensive medications, and those known to affect weight/energy expenditure
- Excessive alcohol intake (self-reported, \>3 drinks/day)
- Musculoskeletal disorders precluding regular physical activity
- Unable to follow either of the two study diets for reasons of food allergies or other (e.g., vegan)
- Currently under psychiatric care, or taking psychiatric medications
- Inability to communicate effectively with study personnel
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
609 Patients enrolled
Trial Details
Trial ID
NCT01826591
Start Date
January 1 2013
End Date
May 1 2016
Last Update
February 21 2023
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305