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

NCT04378322 | Unknown

• 1 other identifier: 102
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

weight loss; digital; nutrition; healthy eating; food purchasing; meal planning; obese; online; MyPlate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Waist circumference

  Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24

• Blood pressure

  Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24

• Change in diet quality

  Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24

Study Arms (3)

Nutrition and food purchasing tool + telenutrition

ACTIVE COMPARATOR

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

Behavioral: Nutrition and food purchasing tool + telenutrition

Nutrition and food purchasing tool

ACTIVE COMPARATOR

Participants will use an online nutrition and food purchasing tool.

Behavioral: Nutrition and food purchasing tool

Nutrition education tool

ACTIVE COMPARATOR

Participants will be exposed to an online nutrition education materials.

Behavioral: Nutrition education tool

Interventions

Nutrition and food purchasing tool + telenutrition BEHAVIORAL

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.

Nutrition and food purchasing tool + telenutrition

Nutrition and food purchasing tool BEHAVIORAL

Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).

Nutrition and food purchasing tool

Nutrition education tool BEHAVIORAL

Participants will be asked to review nutrition education materials online.

Nutrition education tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zipongo: lead

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 4, 2020
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2022
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share