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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01742572
First received: November 27, 2012
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Behavioral: Diet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NEW Dietary Interventions to Enhance the Treatments for Weight Loss (NEW DIETs for Weight Loss Study)

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary Intake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Changes in dietary intake will be measured using 2 days of 24-hour dietary recalls


Enrollment: 63
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vegan
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.
Behavioral: Diet
Change in dietary intake
Experimental: Vegetarian
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.
Behavioral: Diet
Change in dietary intake
Experimental: Pesco-Vegetarian
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.
Behavioral: Diet
Change in dietary intake
Experimental: Semi-Vegetarian
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.
Behavioral: Diet
Change in dietary intake
Active Comparator: Omnivorous
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.
Behavioral: Diet
Change in dietary intake

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742572

Locations
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Brie Turner-McGrievy, PhD, MS, RD University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01742572     History of Changes
Other Study ID Numbers: Pro00021116
Study First Received: November 27, 2012
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
weight loss
obesity
overweight
diet

Additional relevant MeSH terms:
Obesity
Overweight
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014