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

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: Obesity
• Intervention / Treatment: Behavioral: Nutrition and food purchasing tool + telenutrition; Behavioral: Nutrition and food purchasing tool; Behavioral: Nutrition education tool

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

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	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	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	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

• Sponsor: Zipongo

Study record dates

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: nutrition; weight loss; obese; online; healthy eating; digital; MyPlate; food purchasing; meal planning
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• 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