New DIETs: New Dietary Interventions Enhancing the Treatment for Weight Loss - Full Text View

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:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

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

Estimated Enrollment:	75
Study Start Date:	November 2012
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 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

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

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:

Related Info This link exits the ClinicalTrials.gov site

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:	January 22, 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
Weight Loss
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013