Simple Changes Weight Loss Intervention

NCT02968615 | Completed DMC

• 1 other identifier: H00007555
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight

Keywords

fiber; lean protein; loss weight

Outcome Measures

Primary Outcomes (1)

• Weight loss

  kg

  12 weeks

Secondary Outcomes (4)

• Total energy

  12 weeks

• Fiber

  12 weeks

• Protein

  12 weeks

• Saturated fat

  12 weeks

Study Arms (1)

fiber & protein

EXPERIMENTAL

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

Behavioral: Dietary Intervention

Interventions

Dietary Intervention BEHAVIORAL

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.

fiber & protein

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Overweight; Weight Loss

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Yunsheng Ma, MD, Ph.D.

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 18, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

US (1)