Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People

May 4, 2020 updated by: Zipongo
The purpose of this research study is to determine the effectiveness of nutrition tools to support weight loss among obese individuals. All participation will be based online and there will be no in-person visits. Participants will be given nutrition support tools for 6 months. Participants will be asked to report their weight and diet at the start of the study, and every month for 6 months during the study period. Participants will additionally be asked to report weight and diet at 12 months, 18 months, and 24 months after the start of the study. Total study duration will be 2 years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obesity is a major public health burden. Weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers.

The effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown.

Design: This trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and MyPlate optimization.

Participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups.

Participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization.

Participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months.

Population Approximately 300 participants will be enrolled and randomized (100 per arm). Participants will be adults living in New York state who are obese (at least a BMI of 30 kg/m2).

Outcomes Primary outcome: weight change after 6 months Other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

BMI ≥ 30 kg/m2 Male or female 18 or older Non-institutionalized Able and willing to provide informed consent Willing to change diet for 3 months Has access to a scale to weigh themselves Lives in NY state

Exclusion Criteria:

Refuse or are unable to provide informed consent to participate in the study Undergoing active cancer treatment Has type 1 or 2 diabetes Stage 3+ CKD or kidney failure Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months Report of congestive heart failure Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) Current or former Zipongo users

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutrition and food purchasing tool + telenutrition
Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
Behavioral: Nutrition and food purchasing tool + telenutrition
Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.
Active Comparator: Nutrition and food purchasing tool
Participants will use an online nutrition and food purchasing tool.
Behavioral: Nutrition and food purchasing tool
Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
Active Comparator: Nutrition education tool
Participants will be exposed to an online nutrition education materials.
Behavioral: Nutrition education tool
Participants will be asked to review nutrition education materials online.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Weight will be measured using a scale and self-reported.
Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Waist circumference will be measured using a tape measure and self-reported.
Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Blood pressure
Time Frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Blood pressure will be a self-reported assessment at a clinic or pharmacy.
Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Change in diet quality
Time Frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Diet quality will be assessed using a food frequency questionnaire.
Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24

Collaborators and Investigators

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

Sponsor

Zipongo

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 (Anticipated)

May 4, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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