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Simple Changes Weight Loss Intervention

NCT ID: NCT02968615

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Overweight

Keywords

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fiber lean protein loss weight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fiber & protein

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

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Yunsheng Ma

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunsheng Ma, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H00007555

Identifier Type: -

Identifier Source: org_study_id