Clinical trial NCT04378322: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: weight loss
digital
nutrition
healthy eating
food purchasing
meal planning
obese
online
MyPlate
Lead sponsor: Zipongo
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Weight change
timeFrame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
measure: Blood pressure
timeFrame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
measure: Change in diet quality
timeFrame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Other outcomes:
Locations:
Study officials:
References: