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New DIETs: New Dietary Interventions Enhancing the Treatment for Weight Loss (New DIETs)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring weight loss, obesity, overweight, diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be between the ages of 18-65
  • have access to a computer with Internet capabilities
  • be overweight (Body Mass Index of 25-49.9)
  • be able to attend weekly evening meetings at the University of South Carolina in Columbia, SC (up to 8 total) starting late January 2013.

Exclusion Criteria: Participants will be ineligible to participate if they:

  • have a Body Mass Index less than 25 or greater than 49.9 kg/m2
  • are currently pregnant
  • are younger than 18 or older than 65 years of age
  • are unable to attend weekly meetings for 8 weeks
  • don't have access to the Internet and a computer
  • don't have access to a scale for self-monitoring weight
  • aren't willing to be randomized to one of five dietary groups
  • have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
  • have a major health condition, such as heart conditions, diabetes, and past incidence of stroke
  • have an eating disorder (participants will be screened using the Eating Attitudes Test screener-participants who do not pass this screener will be asked to contact their physician)
  • currently participating in a weight loss program or taking weight loss medications
  • currently following a vegan, vegetarian, or pesco-vegetarian diet

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Vegan

Vegetarian

Pesco-Vegetarian

Semi-Vegetarian

Omnivorous

Arm Description

A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask you to keep foods low in fat and low in glycemic index.

A vegetarian diet is one that does not contain meat, fish, or poultry but does contain eggs and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask you to keep foods low in fat and low in glycemic index.

A pesco-vegetarian diet is one that does not contain meat or poultry but does contain fish and shellfish, eggs, and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask you to keep foods low in fat and low in glycemic index.

A semi-vegetarian diet is one that contains all foods, including meat, poultry, fish and shellfish, eggs, and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. However, red meat is limited to one time per week and poultry is limited to 5 times per week or less. We will also ask you to keep foods low in fat and low in glycemic index.

An omnivorous diet contains all food groups. However, as part of this study, we will ask participants in this group to keep foods low in fat and low in glycemic index. Participants in this group will not need to attend weekly meetings but will receive information via e-mail each week.

Outcomes

Primary Outcome Measures

Weight Loss

Secondary Outcome Measures

Dietary Intake
Changes in dietary intake will be measured using 2 days of 24-hour dietary recalls

Full Information

First Posted
November 27, 2012
Last Updated
April 16, 2019
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01742572
Brief Title
New DIETs: New Dietary Interventions Enhancing the Treatment for Weight Loss
Acronym
New DIETs
Official Title
NEW Dietary Interventions to Enhance the Treatments for Weight Loss (NEW DIETs for Weight Loss Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Several studies have shown differences in health-related outcomes by dietary pattern. These patterns have included those participants following vegan (no meat, poultry, fish, dairy, or eggs), vegetarian (no meat, poultry, or fish), pesco- vegetarian (no meat or poultry), semi-vegetarian (red meat and poultry ≥ 1 time/month and < 1 time/week), or omnivorous diets. These studies have shown that of these dietary patterns, vegans have the lowest BMIs, lowest prevalence of Type 2 diabetes, and lowest amount of weight gain over 5 years. In addition, vegetarians have significantly better metabolic risk factors as compared to non-vegetarians. While these initial observational studies have shown benefits to consuming more plant-based diets, there have been no randomized trials examining the differences in health outcomes among these dietary patterns. To begin exploring this research area, the investigators will conduct a pilot study which will randomize participants to one of the 5 dietary approaches. Participants (n=75) in the NEW DIETs Study will be recruited to follow their randomly assigned diet for 8 weeks and attend weekly sessions to learn about nutrition and cooking.
Detailed Description
This study involves five groups. Participants will be randomly assigned to one of these groups. All groups will receive information on a dietary approach aimed at losing weight. All groups will be asked to favor foods that are low fat and have a low glycemic index, which means they will be asked to favor foods that don't cause a quick rise in blood sugar (for example, choosing oatmeal over cornflakes for breakfast). All groups will also be asked to take a vitamin B-12 supplement each day of their choosing (can be a multivitamin). Participants who are eligible on the online screener will be contacted by phone to complete a few additional screening questions and invited to an orientation meeting. Below are the steps in the study: If participants are accepted into the study, participants will come to the study site (USC Public Health Research Center) to learn more about the study, have their weight and height measured, learn how to complete questionnaires online, and complete their consent form. This meeting will last approximately 1.5 hours. Participants will then complete some questionnaires that measure their diet and physical activity levels on a computer at home or other location where participants have computer/internet access. We will also ask participants to keep all their grocery and restaurant receipts during this time to bring back with participants to the next meeting. Participants will come back for a meeting to have their weight measured again and participants will find out their diet group assignment. Participants will receive a 1.25 hour overview of the diet participants have been assigned to and be provided with materials on this diet. If participants are assigned to the vegan, vegetarians, pesco-, or semi-vegetarian diets, they will complete the following over the 8-week study: Participants will attend weekly meetings over 8 weeks. We will obtain their weight and collect online questionnaires at weeks 4 and 8. During the 8-week study, we will ask participants to complete an online weekly questionnaire which will assess if participants are following the diet and their weight. This will take approximately 5 minutes to complete. If participants are assigned to the omnivorous diet, they will only come in for meetings at baseline, 4 weeks, and 8 weeks. We will obtain their weight and collect online questionnaires at weeks 4 and 8. Participants will receive e-mailed lessons of their diet plan each week. During the 8-week study, we will ask participants to complete an online weekly questionnaire which will assess if participants are following the diet, and their weight. This will take approximately 5 minutes to complete. At week 8, participants will also be provided with information about the other 4 diets in case participants would like to try these dietary patterns after the study. All diet groups will be asked to collect and turn in all grocery store and restaurant receipts for 2 weeks prior to the start of the intervention and for the 8 weeks during the study. At study completion (8 weeks), participants will receive an incentive for participating ($20). Participants in all groups will be asked to take a daily multivitamin (or other reliable source of vitamin B-12) over the course of the study. You are responsible for choosing and purchasing this. During the study, we will ask you to keep your physical activity levels constant (keep your levels the same as what you were doing at study entry).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
weight loss, obesity, overweight, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegan
Arm Type
Experimental
Arm Description
A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask you to keep foods low in fat and low in glycemic index.
Arm Title
Vegetarian
Arm Type
Experimental
Arm Description
A vegetarian diet is one that does not contain meat, fish, or poultry but does contain eggs and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask you to keep foods low in fat and low in glycemic index.
Arm Title
Pesco-Vegetarian
Arm Type
Experimental
Arm Description
A pesco-vegetarian diet is one that does not contain meat or poultry but does contain fish and shellfish, eggs, and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. We will also ask you to keep foods low in fat and low in glycemic index.
Arm Title
Semi-Vegetarian
Arm Type
Experimental
Arm Description
A semi-vegetarian diet is one that contains all foods, including meat, poultry, fish and shellfish, eggs, and dairy, in addition to plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. However, red meat is limited to one time per week and poultry is limited to 5 times per week or less. We will also ask you to keep foods low in fat and low in glycemic index.
Arm Title
Omnivorous
Arm Type
Active Comparator
Arm Description
An omnivorous diet contains all food groups. However, as part of this study, we will ask participants in this group to keep foods low in fat and low in glycemic index. Participants in this group will not need to attend weekly meetings but will receive information via e-mail each week.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Change in dietary intake
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dietary Intake
Description
Changes in dietary intake will be measured using 2 days of 24-hour dietary recalls
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: be between the ages of 18-65 have access to a computer with Internet capabilities be overweight (Body Mass Index of 25-49.9) be able to attend weekly evening meetings at the University of South Carolina in Columbia, SC (up to 8 total) starting late January 2013. Exclusion Criteria: Participants will be ineligible to participate if they: have a Body Mass Index less than 25 or greater than 49.9 kg/m2 are currently pregnant are younger than 18 or older than 65 years of age are unable to attend weekly meetings for 8 weeks don't have access to the Internet and a computer don't have access to a scale for self-monitoring weight aren't willing to be randomized to one of five dietary groups have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition have a major health condition, such as heart conditions, diabetes, and past incidence of stroke have an eating disorder (participants will be screened using the Eating Attitudes Test screener-participants who do not pass this screener will be asked to contact their physician) currently participating in a weight loss program or taking weight loss medications currently following a vegan, vegetarian, or pesco-vegetarian diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brie Turner-McGrievy, PhD, MS, RD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25532675
Citation
Turner-McGrievy GM, Wirth MD, Shivappa N, Wingard EE, Fayad R, Wilcox S, Frongillo EA, Hebert JR. Randomization to plant-based dietary approaches leads to larger short-term improvements in Dietary Inflammatory Index scores and macronutrient intake compared with diets that contain meat. Nutr Res. 2015 Feb;35(2):97-106. doi: 10.1016/j.nutres.2014.11.007. Epub 2014 Dec 3.
Results Reference
derived

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New DIETs: New Dietary Interventions Enhancing the Treatment for Weight Loss

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