Simple Changes Weight Loss Intervention

Not Applicable

Completed

• Conditions: Overweight

• Registration Number: NCT02968615
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-06
• Study Completion: 2016-04
• Status Verified: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-16
• Last Update Submitted: 2016-11-16
• Study First Posted: 2016-11-18
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weight loss	12 weeks	kg

Secondary Outcome Measures

Name	Time	Method
Protein	12 weeks	g/day
Total energy	12 weeks	kcal/day
Fiber	12 weeks	g/day
Saturated fat	12 weeks	percent of calories

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States