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

2018年11月27日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

52

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15261
        • Physical Activity and Weight Management Research Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~55年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Cardiorespiratory Fitness
時間枠: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
時間枠:Baseline (0 weeks),12 Weeks
Measured in kilograms using a digital scale
Baseline (0 weeks),12 Weeks
Change in Fat Mass
時間枠: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
時間枠:Baseline (0 weeks),12 Weeks
Measured as kcal/day using a questionnaire
Baseline (0 weeks),12 Weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Seth A Creasy、University of Pittsburgh
  • スタディチェア:John M Jakicic、University of Pittsburgh

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年2月1日

一次修了 (実際)

2016年8月1日

研究の完了 (実際)

2016年8月1日

試験登録日

最初に提出

2016年2月23日

QC基準を満たした最初の提出物

2016年2月23日

最初の投稿 (見積もり)

2016年2月26日

学習記録の更新

投稿された最後の更新 (実際)

2018年11月29日

QC基準を満たした最後の更新が送信されました

2018年11月27日

最終確認日

2018年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PRO15110570

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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