Simple Changes Weight Loss Intervention

Overweight Clinical Trial

Official title:

Simple Changes Weight Loss Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968615
• Other study ID #: H00007555
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 16, 2016
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight Changes
• Overweight
• Weight Loss

Intervention

Behavioral:
• Dietary Intervention
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. Patients in both conditions will receive intensive dietary instruction for 6 weeks, followed by a 6 weeks maintenance phase. Participants received dietary instructions via individual and group sessions led by registered dietitians.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	kg	12 weeks	No
Secondary	Total energy	kcal/day	12 weeks	No
Secondary	Fiber	g/day	12 weeks	No
Secondary	Protein	g/day	12 weeks	No
Secondary	Saturated fat	percent of calories	12 weeks	Yes