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Simple Changes Weight Loss Intervention

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring fiber, lean protein, loss weight

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fiber & protein

Arm Description

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

Outcomes

Primary Outcome Measures

Weight loss
kg

Secondary Outcome Measures

Total energy
kcal/day
Fiber
g/day
Protein
g/day
Saturated fat
percent of calories

Full Information

First Posted
November 7, 2016
Last Updated
November 16, 2016
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT02968615
Brief Title
Simple Changes Weight Loss Intervention
Official Title
Simple Changes Weight Loss Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
fiber, lean protein, loss weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fiber & protein
Arm Type
Experimental
Arm Description
A single dietary change condition that focuses exclusively on increasing fiber and protein.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Intervention 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. 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.
Primary Outcome Measure Information:
Title
Weight loss
Description
kg
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total energy
Description
kcal/day
Time Frame
12 weeks
Title
Fiber
Description
g/day
Time Frame
12 weeks
Title
Protein
Description
g/day
Time Frame
12 weeks
Title
Saturated fat
Description
percent of calories
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunsheng Ma, MD, Ph.D.
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Please contact with PI

Learn more about this trial

Simple Changes Weight Loss Intervention

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