Simple Changes Weight Loss Intervention

University of Massachusetts, Worcester

Status: Completed

Conditions: Overweight

Treatments: Behavioral: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02968615

H00007555

Details and patient eligibility

About

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).

Full description

Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Loss of 5% of their body weight are considered to achieve the weight-loss goal. The intervention included 6 bi-weekly, 30-minute individual dietary counseling sessions over 12-weeks. Behavioral strategies including self-monitoring, problem solving, goal setting, stimulus control, food substitution, and relapse prevention were taught to assist participants in meeting their fiber and protein goals.

Enrollment: 15 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. interested in losing weight and have a body mass index (BMI) 30-45 kg/m2;
2. ages 21 to 70;
3. able to provide informed consent;
4. physician's approval of his/her patients to participate;
5. non-smoker (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect on weight

Exclusion criteria

1. clinically diagnosed diabetes, or an HbA1c ≥ 6.5%;
2. an acute coronary event within the previous 6 months;
3. pregnant or lactating;
4. plans to move out of the area within the 12-week study period;
5. diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., inflammatory bowel disease, active diverticulitis, renal disease);
6. following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet or participating in a weight loss program;
7. previously had bariatric surgery;
8. currently using weight loss medication;
9. diagnosis of an eating disorder (anorexia nervosa, bulimia nervosa or binge eating);
10. unable to provide consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

fiber & protein

Experimental group

Description:

A single dietary change condition that focuses exclusively on increasing fiber and protein.

Treatment:

Behavioral: Dietary Intervention