Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Weight change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Nutrition and food purchasing tool + telenutrition
Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
Intervention: Nutrition and food purchasing tool + telenutrition (Behavioral)
Nutrition and food purchasing tool
Participants will use an online nutrition and food purchasing tool.
Intervention: Nutrition and food purchasing tool (Behavioral)
Nutrition education tool
Participants will be exposed to an online nutrition education materials.
Intervention: Nutrition education tool (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)