Simple Changes Weight Loss Intervention

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Behavioral: Dietary Intervention

• 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

Arm && Interventions

Group	Intervention	Description
fiber & protein	Dietary Intervention	A single dietary change condition that focuses exclusively on increasing fiber and protein.

Primary Outcome Measures

Name	Time	Method
Weight loss	12 weeks	kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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