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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition and food purchasing tool + telenutrition
Nutrition and food purchasing tool
Nutrition education tool
Sponsored by
Zipongo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring weight loss, digital, nutrition, healthy eating, food purchasing, meal planning, obese, online, MyPlate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Nutrition and food purchasing tool + telenutrition

    Nutrition and food purchasing tool

    Nutrition education tool

    Arm Description

    Participants will use an online nutrition and food purchasing tool in addition to telenutrition.

    Participants will use an online nutrition and food purchasing tool.

    Participants will be exposed to an online nutrition education materials.

    Outcomes

    Primary Outcome Measures

    Weight change
    Weight will be measured using a scale and self-reported.

    Secondary Outcome Measures

    Waist circumference
    Waist circumference will be measured using a tape measure and self-reported.
    Blood pressure
    Blood pressure will be a self-reported assessment at a clinic or pharmacy.
    Change in diet quality
    Diet quality will be assessed using a food frequency questionnaire.

    Full Information

    First Posted
    May 4, 2020
    Last Updated
    May 4, 2020
    Sponsor
    Zipongo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04378322
    Brief Title
    Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
    Official Title
    Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 4, 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zipongo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    weight loss, digital, nutrition, healthy eating, food purchasing, meal planning, obese, online, MyPlate

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrition and food purchasing tool + telenutrition
    Arm Type
    Active Comparator
    Arm Description
    Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
    Arm Title
    Nutrition and food purchasing tool
    Arm Type
    Active Comparator
    Arm Description
    Participants will use an online nutrition and food purchasing tool.
    Arm Title
    Nutrition education tool
    Arm Type
    Active Comparator
    Arm Description
    Participants will be exposed to an online nutrition education materials.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition and food purchasing tool + telenutrition
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition and food purchasing tool
    Intervention Description
    Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition education tool
    Intervention Description
    Participants will be asked to review nutrition education materials online.
    Primary Outcome Measure Information:
    Title
    Weight change
    Description
    Weight will be measured using a scale and self-reported.
    Time Frame
    Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
    Secondary Outcome Measure Information:
    Title
    Waist circumference
    Description
    Waist circumference will be measured using a tape measure and self-reported.
    Time Frame
    Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
    Title
    Blood pressure
    Description
    Blood pressure will be a self-reported assessment at a clinic or pharmacy.
    Time Frame
    Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
    Title
    Change in diet quality
    Description
    Diet quality will be assessed using a food frequency questionnaire.
    Time Frame
    Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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