The BMI Project (Body, Mind, Inflammation)
A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults
Obesity and chronic inflammation influence the development and progression of many types of cancer. These conditions share several of the same causes, including physical inactivity, poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an important developmental period in which to address behaviors and psychological variables that affect both weight status and inflammation. At least 40% of emerging adults have overweight/obesity, and this transition from adolescence to early adulthood is associated with significant increases in fast food consumption, decreases in physical activity, unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress.
Despite this high risk for obesity, very few weight loss interventions are designed specifically for emerging adults. Preliminary findings from weight loss interventions targeting this population have shown some promise, but generally produce modest outcomes with less consistent effects than programs in older adults. Depression and stress have been found to interfere with weight loss among emerging adults, and may be in part responsible for poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention (ILI) that comprehensively addresses both psychological distress and traditional weight management targets. This novel approach has not been tested before and has the potential not only to enhance weight loss outcomes in this high risk population, but also to produce reductions in markers of inflammation beyond those achievable by weight loss alone.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Virginia
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Richmond, Virginia, 미국, 23219
- Virginia Commonwealth University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 18 and 25 years
- Body Mass Index between 25 and 45 kg/m2
Exclusion Criteria:
- Currently pregnant or lactating; pregnancy in the last 6 months or plans to become pregnant in the next 6 months
- Type 1 or type 2 diabetes
- Any uncontrolled medical conditions that could make it unsafe to participate in unsupervised exercise
- Medical conditions associated with chronic inflammation
- Inability to read, understand and speak English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Integrated Lifestyle Intervention
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This program is grounded in data demonstrating the dysregulation across multiple domains and considerable life stressors experienced by this population.
The central hypothesis is that by simultaneously ameliorating psychological dysregulation and directly targeting proinflammatory behaviors, ILI operates on multiple proposed mediators of poor treatment outcomes in this population, thereby enhancing treatment outcomes.
As such, the overall framework emphasizes integration of self-regulation as it applies to both psychological functioning and weight control.
Content will highlight the interconnectedness of mood, stress, eating and exercise behaviors, and risk for inflammation and disease.
Each treatment session will present a combination of behavioral and psychological content, representing a truly integrated approach.
Participants will meet for 75-minute group sessions weekly for months 1-2, followed by bi-weekly groups in months 3-4, for a total of 12 groups.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of sessions attended throughout the intervention period
기간: 4 months
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Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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4 months
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Number of days self-monitoring weight in LoseIt
기간: 4 months
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Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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4 months
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Number of days self-monitoring weight-related behaviors in LoseIt
기간: 4 months
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Self-monitoring of weight-related behaviors (e.g., diet and physical activity) is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in diet
기간: Baseline and 4 months
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Dietary change will be assessed using the Diet History Questionnaire III (DHQ-III), a 166-item adaptive questionnaire developed by NCI which maps on to dietary intervention targets (e.g., saturated fat, alcohol, sugar, fiber, sodium), as well as a measure of overall diet.
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Baseline and 4 months
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Change in physical activity
기간: Baseline and 4 months
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Participants will report their physical activity using the 6-item Paffenbarger Physical Activity Questionnaire, which yields estimates of minutes spent in moderate-to-vigorous physical activity.
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Baseline and 4 months
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Change in sleep
기간: Baseline and 4 months
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The EARLY Trials Common Elements Sleep Questionnaire (8 items) will be administered that asks about duration of sleep and problems encountered during sleep (e.g.
snoring).
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Baseline and 4 months
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Percent Weight Change
기간: Baseline and 4 months
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Weight will be measured in light clothes, without shoes, on calibrated Tanita BWB-800S scales.
Percent change of initial body weight will be calculated using baseline and 4 month weights.
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Baseline and 4 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jessica LaRose, PhD, Virginia Commonwealth University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- MCC-18-14509
- HM20015075 (기타 식별자: Virginia Commonwealth University IRB)
- NCI-2019-04792 (기타 식별자: National Cancer Institute)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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