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Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults

2014年1月3日 更新者:David Garcia、University of Pittsburgh
The purpose of this study is to examine the feasibility of a campaign intervention for weight management compared to a standard behavioral weight loss intervention in overweight and obese adults.

調査の概要

詳細な説明

The feasibility of solely using a campaign intervention (CI) to promote healthy eating and physical activity behaviors for weight loss and weight maintenance has not been examined in a systematic manner. Thus, the primary aim of this study will be to examine whether a stand-alone CI results in similar weight loss compared to a standard behavioral weight loss intervention (SBWL). It is hypothesized that the CI will achieve a similar weight loss when compared to the SBWL. Additional aims include the examination of the CI on changes in moderate to vigorous intensity physical activity, dietary intake, self-monitoring of dietary intake and physical activity, weight loss self-efficacy, and motivation compared to a SBWL. This study will recruit forty-eight sedentary, overweight and obese adult men and women, to participate in a behavioral weight loss intervention at the University of Pittsburgh Physical Activity and Weight Management Research Center (PAWMRC). To be considered eligible for this study, participants must be 18-55 years of age, with a Body Mass Index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m². Assessments will be conducted at week 0 and 12 of the intervention. Each assessment will take approximately 30 minutes to complete and include height, body weight, and assessment of physical activity, dietary intake, weight loss self-efficacy, and motivation. Upon successful completion of baseline assessments, eligible subjects will be randomly assigned to one of two groups using a stratified randomized block design: 1) standard behavioral weight loss intervention (SBWL) or 2) campaign intervention (CI). The CI will target specific diet and physical activity behaviors to improve weight loss efforts within a thematic framework based on the professional auto racing point system concept. CI session content and targeted behavior goals will tie into this overall theme and throughout the campaign participants will have the opportunity to earn incentives to reinforce positive behavior changes. This study is a necessary first step to examine the feasibility of a stand-alone campaign as an alternative strategy for weight management when compared to a standard behavioral weight loss intervention. Furthermore, this study will provide variance estimates on the effectiveness of a campaign intervention compared to a standard behavioral weight loss program that can be used to determine appropriate sample sizes for a future full-scale clinical study of this alternative strategy.

研究の種類

介入

入学 (実際)

26

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、15217
        • University of Pittsburgh 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

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 18-55 years of age
  • Body mass index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m²
  • Ability to provide informed consent

Exclusion Criteria:

  • Regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months.
  • Participation in a previous physical activity or weight management research project in the previous 6 months.
  • Weight loss of ≥5% of current body weight in the previous 6 months.
  • For women, those currently pregnant, pregnant during the previous 6 months, or plan on becoming pregnant in the next 6 months.
  • History of myocardial infarction, coronary bypass surgery, angioplasty, or other heart-related surgeries.
  • History of orthopedic or physical complications that would prevent participation in exercise.
  • Currently taking any prescription medication that may affect metabolism and/or body weight (e.g., synthroid).
  • Currently being treated for any condition that could affect body weight, such as coronary heart disease, diabetes mellitus, uncontrolled hypertension, cancer, depression, and anxiety.
  • Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
  • Resting systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg. Subjects with controlled hypertension will be allowed to participate if they obtain a medical doctor's written consent to ensure that it is safe to participate in a weight loss intervention.
  • Currently do not have access to a computer and the Internet.

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Standard Behavioral Weight Loss Intervention (SBWL)
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
実験的:Campaign Intervention (CI)
Included changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
Included changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.

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 Body Weight
時間枠:Week 0 and 12
Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.
Week 0 and 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Physical Activity
時間枠:Week 0 and 12
A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Week 0 and 12
Change in Dietary Intake: Kcals/Day
時間枠:Week 0 and 12
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Week 0 and 12
Change in Dietary Intake: % Fat
時間枠:Week 0 and 12
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Week 0 and 12
Change in Dietary Intake: % Protein
時間枠:Week 0 and 12
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Week 0 and 12
Change in Dietary Intake: % Carbohydrate
時間枠:Week 0 and 12
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Week 0 and 12
Completion of Self-monitoring of Dietary Intake and Physical Activity
時間枠:Week 0 and 12
The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.
Week 0 and 12
Change in Weight Loss Self-efficacy
時間枠:Week 0 and 12
Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.
Week 0 and 12
Autonomous and Controlled Motivation
時間枠:Week 12
At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants' reasons for continuing participation in a weight loss program via participants' endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.
Week 12

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:David O Garcia, MS、University of Pittsburgh

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2013年1月1日

一次修了 (実際)

2013年7月1日

研究の完了 (実際)

2013年7月1日

試験登録日

最初に提出

2013年2月28日

QC基準を満たした最初の提出物

2013年3月1日

最初の投稿 (見積もり)

2013年3月4日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年2月17日

QC基準を満たした最後の更新が送信されました

2014年1月3日

最終確認日

2014年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • PRO12110211

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