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Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults (REACH)

2018년 11월 27일 업데이트: John M. Jakicic, PhD, University of Pittsburgh

Comparison of Supervised and Unsupervised Physical Activity Programs During a Standard Behavioral Weight Loss Intervention for Adults Who Are Overweight or Obese

Adults who are overweight or obese are typically prescribed a calorie-restricted diet and physical activity to promote weight loss and improve health. The manner in which physical activity is prescribed and monitored may influence physical activity engagement. Within the context of clinical research, physical activity has been prescribed in either a supervised or unsupervised manner. Supervised physical activity is typically done in a health-fitness facility under the direct supervision of trained staff. The alternative, unsupervised physical activity, promotes physical activity participation in a setting that is convenient to the individual. Unsupervised activity can be done in any environment or at any time that best suits the individual. Knowing the effects of unsupervised physical activity is important because of the translation of this type of physical activity to non-research settings. Therefore, knowing the magnitude of the physiological effects of unsupervised physical activity compared to supervised physical activity at the same prescribed intensity and dose is of clinical and public health importance. This study is designed to provide insight on these important research questions that can inform future research and the application to clinical, public health, and health-fitness settings.

연구 개요

상세 설명

Approximately 69% of the U.S. adult population is overweight, defined by a body mass index (BMI) of ≥ 25.0 kg/m2, and 35% are obese (BMI ≥ 30.0 kg/m2), with the prevalence of overweight and obesity rising drastically over the past several decades. Adults who are overweight or obese are typically recommended to change lifestyle factors (e.g. diet, physical activity, etc.) to lose weight and improve health. When evaluating the effects of these lifestyle changes on weight and health in a research setting, physical activity is supervised (i.e. physical activity completed in a health-fitness facility with direct supervision from trained staff). With supervised physical activity, researchers are able to quantify the frequency, intensity, duration, and type of physical activity. Thus, supervised physical activity is considered the gold-standard when evaluating the effects of physical activity on weight and other physiological parameters. However, the results of supervised physical activity trials may not translate to clinical settings. A typical clinical approach prescribes physical activity in an unsupervised manner (i.e. physician tells patient to be more physically active or take more steps/day). Unsupervised physical activity can be done in any environment or at any time that best suits the individual. Knowing the effects of unsupervised physical activity is important because of the translation of this type of physical activity to non-research settings. Therefore, knowing the magnitude of the physiological effects of unsupervised physical activity compared to supervised physical activity at the same prescribed intensity and dose is of clinical and public health importance especially in an overweight and obese population. This study is designed to provide insight on these important research questions that can inform future research and the application to clinical, public health, and health-fitness settings.

Participants will be randomized to one of three groups: supervised physical activity prescribed in min/week (SUP-PA), unsupervised physical activity prescribed in min/week (UNSUP-PA), and unsupervised physical activity prescribed in steps/day (STEP). Participants in all three groups will participate in a behavioral weight loss intervention which includes dietary counseling and weekly group sessions during the 12-week program. SUP-PA will be prescribed 150 minutes/week of moderate-to-vigorous physical activity (MVPA) completed under direct supervision of trained staff at a designated health-fitness facility. UNSUP-PA will be prescribed a physical activity dose matched to SUP-PA. STEP will be prescribed a 10,000 step/day recommendation with 2,500 of those steps completed at a "brisk" pace. The primary aim of this study is to compare the effects of all three groups on moderate-to-vigorous physical activity (MVPA) accumulated in bouts of at least 10 minutes. The primary outcome will be assessed at baseline, week 4, week 8, and week 12. Secondary aims of this trial include comparing light intensity physical activity, sedentary time, cardiorespiratory fitness, weight, body composition, waist circumference measures, physical activity self-efficacy, blood pressure, and dietary intake across all three groups. Secondary aims will be assessed at baseline and week 12.

연구 유형

중재적

등록 (실제)

52

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15261
        • Physical Activity and Weight Management Research Center

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

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Male or Female
  • Aged 18-55 years old
  • BMI of 25.0 to <40.0 kg/m2
  • Ability to provide informed consent
  • Ability to provide physician's clearance to participate in a weight loss intervention

Exclusion Criteria:

  • Engaging in >60 min/wk (accumulated in bouts of ≥10 minutes) of moderate-to-vigorous physical activity over the past month
  • Presence of contraindications to physical activity as identified on a physical activity readiness questionnaire (PAR-Q)
  • History of metabolic, cardiac, or pulmonary disease that classifies the individual as high risk by the American College of Sports Medicine (e.g., coronary heart disease, diabetes mellitus, uncontrolled hypertension, etc.)
  • History of myocardial infarction, coronary bypass surgery, angioplasty, or other cardiovascular- related surgeries.
  • Taking medication that may affect heart rate or blood pressure responses to physical activity
  • Resting systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg.
  • Medication that may affect body weight/metabolism (e.g., synthroid).
  • Current or previous participation in a physical activity or weight management research project in the past 6 months
  • Weight loss of ≥5% or 15 pounds total of current body weight in the previous 6 months.
  • Currently being treated for an eating disorder (e.g., anorexia, bulimia, etc.)
  • Previously undergone bariatric surgery (e.g., lap-band, gastric bypass, etc.)
  • For women, those currently pregnant, pregnant during the previous 6 months, or plan on becoming pregnant in the next 6 months
  • Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
  • Being out of town during for an extended amount of time during the weight loss intervention which may affect participation in the study
  • Currently using a physical activity monitor to track activity (e.g., Jawbone UP, Fitbit, etc.)

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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Supervised (SUP-PA)
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
실험적: Unsupervised (UNSUP-PA)
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
실험적: Step-based (STEP)
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
기간: Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks
Measured using a wearable device and by questionnaire
Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Cardiorespiratory Fitness
기간: Baseline (0 weeks),12 Weeks
Measured using a submaximal graded exercise test on a treadmill, with termination occurring at 85% of age-predicted maximal heart rate (computed at [220-age]*0.85]). The outcome was measures as oxygen consumption (ml/kg/min) at the point of test termination.
Baseline (0 weeks),12 Weeks
Change in Body Weight
기간: Baseline (0 weeks),12 Weeks
Measured in kilograms using a digital scale
Baseline (0 weeks),12 Weeks
Change in Fat Mass
기간: Baseline (0 weeks),12 Weeks
Measured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA)
Baseline (0 weeks),12 Weeks
Change in Energy Intake
기간: Baseline (0 weeks),12 Weeks
Measured as kcal/day using a questionnaire
Baseline (0 weeks),12 Weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Seth A Creasy, University of Pittsburgh
  • 연구 의자: John M Jakicic, University of Pittsburgh

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

2016년 2월 1일

기본 완료 (실제)

2016년 8월 1일

연구 완료 (실제)

2016년 8월 1일

연구 등록 날짜

최초 제출

2016년 2월 23일

QC 기준을 충족하는 최초 제출

2016년 2월 23일

처음 게시됨 (추정)

2016년 2월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 11월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 11월 27일

마지막으로 확인됨

2018년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PRO15110570

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

Supervised (SUP-PA)에 대한 임상 시험

3
구독하다