Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Nutrition and food purchasing tool + telenutrition
Participants will use an online nutrition and food purchasing tool in addition to telenutrition.
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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.
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활성 비교기: Nutrition and food purchasing tool
Participants will use an online nutrition and food purchasing tool.
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Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
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활성 비교기: Nutrition education tool
Participants will be exposed to an online nutrition education materials.
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Participants will be asked to review nutrition education materials online.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weight change
기간: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Weight will be measured using a scale and self-reported.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Waist circumference
기간: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Waist circumference will be measured using a tape measure and self-reported.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Blood pressure
기간: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Blood pressure will be a self-reported assessment at a clinic or pharmacy.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Change in diet quality
기간: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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Diet quality will be assessed using a food frequency questionnaire.
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Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .