Simplifying Diet Tracking in a Digital Weight Loss Intervention
2026년 5월 22일 업데이트: Michele Patel, Stanford University
Simplifying Dietary Self-Monitoring in a Digital Weight Loss Intervention
The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss.
The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
328
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Study Team
- 전화번호: 650-549-7047
- 이메일: mlp9@stanford.edu
연구 장소
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California
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Palo Alto, California, 미국, 94304
- Stanford University School of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- smartphone ownership
- willing to install a mobile app on personal smartphone
- access to a personal email account
- English or Spanish language proficiency
- interest in losing weight through behavioral strategies
- living in the United States
- willing to be randomized
Exclusion Criteria:
- concurrent enrollment in another weight management intervention
- loss of ≥5% weight in the past 6 months
- prior or planned bariatric surgery during the trial period
- current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months
- currently breastfeeding or lactating
- current use of anti-obesity medications
- living with someone else participating in the study
- hospitalization for a mental health condition in the past 12 months
- inability to engage in moderate forms of physical activity akin to brisk walking
- medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication)
- if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus)
- investigator discretion for safety reasons
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Simplified (Track Red Zone Foods)
Simplified + Core
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Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist.
Participants receive a daily Red Zone Food goal.
All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback.
The intervention will be delivered remotely via email and/or text message.
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실험적: Detailed (Track All Foods/Calories)
Detailed + Core
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All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback.
The intervention will be delivered remotely via email and/or text message.
Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app.
Participants receive a daily calorie goal.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weight Change from Baseline to 12 Months
기간: Baseline, 12 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking)
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Baseline, 12 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weight Change from Baseline to 1 Month
기간: Baseline, 1 Month
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 1 Month
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Weight Change from Baseline to 6 Months
기간: Baseline, 6 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 6 Months
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Weight Change from Baseline to 18 Months
기간: Baseline, 18 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 18 Months
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Caloric Intake Change from Baseline to 12 Months
기간: Baseline, 12 Months
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mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day
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Baseline, 12 Months
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Diet Quality Change from Baseline to 12 Months
기간: Baseline, 12 Months
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mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality
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Baseline, 12 Months
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Step Count Change from Baseline to 12 Months
기간: Baseline, 12 Months
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mean change in step count; assessed objectively via activity tracker
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Baseline, 12 Months
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Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months
기간: Baseline, 12 Months
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mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
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Baseline, 12 Months
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Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months
기간: Baseline, 12 Months
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mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
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Baseline, 12 Months
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Engagement in Self-Monitoring Dietary Intake
기간: daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Engagement in Self-Monitoring Weight
기간: daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Engagement in Self-Monitoring Steps
기간: daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michele L. Patel, PhD, Stanford University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 5월 1일
기본 완료 (추정된)
2030년 4월 30일
연구 완료 (추정된)
2030년 10월 31일
연구 등록 날짜
최초 제출
2026년 5월 14일
QC 기준을 충족하는 최초 제출
2026년 5월 14일
처음 게시됨 (실제)
2026년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 22일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 87051
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The de-identified dataset and metadata will be made available through a public repository.
It will include the primary outcome (weight change), secondary outcomes, and participant level characteristics.
Data will be available in an Excel spreadsheet, whereby each row corresponds to a unique participant's data, and columns represent the different variables mentioned, by time point.
IPD 공유 기간
The shared dataset and metadata will be preserved and made publicly available to share for at least 3 years following completion of the project, in accordance with NIH regulations.
They will be made available upon publication of the primary outcomes paper in a peer-reviewed journal, or at the end of the grant period (whichever comes first).
IPD 공유 액세스 기준
Publicly available.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .