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

April 16, 2019 updated by: Brie Turner-McGrievy, University of South Carolina

NEW Dietary Interventions to Enhance the Treatments for Weight Loss (NEW DIETs for Weight Loss Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

    1. Participants will attend weekly meetings over 8 weeks.
    2. We will obtain their weight and collect online questionnaires at weeks 4 and 8.
    3. 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.

    1. We will obtain their weight and collect online questionnaires at weeks 4 and 8.
    2. Participants will receive e-mailed lessons of their diet plan each week.
    3. 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.
    4. 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Weight Loss
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary Intake
Time Frame: 8 weeks
Changes in dietary intake will be measured using 2 days of 24-hour dietary recalls
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brie Turner-McGrievy, PhD, MS, RD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00021116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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