Simple Changes Weight Loss Intervention
Completed · Not applicable
Conditions studied: Overweight
In brief
The investigators examined feasibility and acceptability of a non-restrictive diet focused on increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a 12-week assessment which included 6 bi-weekly individual dietary counseling sessions to attain a daily goal of higher fiber (\>35 g/day) and lean protein (0.8 g per kilogram/day of individual's ideal body weight).
Key facts
- Study ID
- NCT02968615
- Run by
- University of Massachusetts, Worcester
- People needed
- 15
- Starts
- 2015-05-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-11-18
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- interested in losing weight and have a body mass index (BMI) 30-45 kg/m2;
- ages 21 to 70;
- able to provide informed consent;
- physician's approval of his/her patients to participate;
- non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect on weight
You may not qualify if…
- clinically diagnosed diabetes, or an HbA1c ≥ 6.5%;
- an acute coronary event within the previous 6 months;
- pregnant or lactating;
- plans to move out of the area within the 12-week study period;
- diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease);
- following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or participating in a weight loss program;
- previously had bariatric surgery;
- currently using weight loss medication;
- diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating);
- unable to provide consent.
Where it is running
- University of Massachusetts Medical School — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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