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Effects of Journaling on Weight Loss

2013年1月31日 更新者:Christopher Sciamanna, MD, MPH、Milton S. Hershey Medical Center
This is a randomized controlled trial with enhanced usual care treatment control. The aim is to determine the effects of journaling and use of resource website on weight loss. There will be two groups of 55 participants each. The intervention condition will be asked to record daily weight, physical activity steps taken and pre-portioned food items and to complete two daily journaling activities. Participants will also receive weekly tracing data, a weekly blog from the principal investigator and have access to a weight control website. The control group will not have access to the tracking, journaling or website for three months. Investigators hypothesize that a website paired with tracking and journaling will be more effective in helping participants lose weight.

調査の概要

詳細な説明

Participants will call study line given on recruitment materials and be screened over the phone.

Baseline visit:

Individuals who meet the screening criteria will be invited to a one-hour training session about the website and diet plan book. During the training, a coordinator will review the consent form with the participants and ask if they have any questions. The coordinator will take consented individuals' height, weight and blood pressure measurements. Participants will be given a pedometer to use during physical activities and a meal replacement book to use as a resource.

After baseline visit:

All participants will complete surveys online (Demographics, Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire) and be randomized into one of two groups. The intervention group will be asked to record their weight, physical activity steps, pre-portioned food items and journal entries on a daily basis. The control group will be sent an email informing them they will have access to the tracking, journals and website in three months.

Intervention Group:

Participants will receive daily emails with links to record their weight, physical activity steps and pre-portioned food items; participants will also complete a journaling response to two writing prompts. The emails will contain links to the website to be used as a resource. Every week, participants will enter whether they have an appointment with primary care provider in the next week. Participants will also receive weekly blogs from the principal investigator; participants can opt out of receiving the blog emails at any time. Coordinators will review the database weekly. If a participant has lost ten pounds, they will be emailed to call their doctor since weight loss can affect blood pressure and medication needs. If a participant has an upcoming primary care provider appointment, they will be emailed to print out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also monitor journal responses; coordinators will contact participants who wrote useful entries to ask if the participant's responses can be shared with other participants. Shared posts will be anonymous; only the age of the individual will be given.

Month one and two visits:

Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured.

Month three visit:

Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured. Prior to their visit, participants will be asked to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction). Participants in the control group will be given a booklet containing the writing prompts, tracking and website address to complete on their own if they so choose.

Participants will be asked if they would like to come back for an optional video interview. The interview will consist of six questions about their experience with the study.

研究の種類

介入

入学 (実際)

100

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
      • Hershey、Pennsylvania、アメリカ、17033
        • Penn State Milton S. Hershey Medical 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

21年~65年 (大人、高齢者)

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:

  • 21 to 65 years old
  • Body mass index between 27 and 45
  • E-mail and Internet access
  • Able to read, write, and understand English

Exclusion Criteria:

  • Weight loss of more than 5% of current body weight in previous 6 months
  • Participated in weight loss research in previous 6 months
  • Current use of weight loss medication or program
  • History of or scheduled weight loss surgery
  • Heart, liver, or kidney failure
  • Been told by doctor of heart trouble
  • Frequent pains in heart and chest
  • Often feel faint or have spells of severe dizziness
  • Bone or joint problem that has been or might be aggravated by exercise
  • Physical reason for not following activity program
  • History of sever cognitive impairment or major psychiatric illness
  • Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
  • Moving in next 6 months

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
実験的:Tracking + Journaling + Website
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
Participants will record their daily weight, physical activity steps and meal replacements online
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.
アクティブコンパレータ:Enhanced Usual Care
Participants receive standard care
Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.

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
Weight
時間枠:3 months
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Blood Pressure
時間枠:3 months
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
3 months
Height
時間枠:3 months
Height will be measured using a portable stadiometer.
3 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Sociodemographics and tobacco use
時間枠:3 months
Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
3 months
Three-factor Eating Questionnaire
時間枠:3 months
Questionnaire asks participants about how their dietary restraint in specific circumstances
3 months
Motivation
時間枠:3 months
Questionnaire asks participants to gauge their motivation to lose weight.
3 months
Weight Loss Habits
時間枠:3 months
Questionnaire asks participants how often they use specific habits to lose weight
3 months
Blood Pressure Medication
時間枠:3 months
Blood pressure medication names, doses and frequency measured by self-report
3 months
International Physical Activity Questionnaire
時間枠:3 months
Questionnaire asks participants to estimate the frequency and duration of specific physical activities
3 months
Satisfaction Survey
時間枠:3 months
Questionnaire asks participants about their satisfaction with specific aspects of the study
3 months

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。

捜査官

  • 主任研究者:Christopher Sciamanna, MD, MPH、Milton S. Hershey Medical Center

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

2012年8月1日

一次修了 (実際)

2013年1月1日

研究の完了 (実際)

2013年1月1日

試験登録日

最初に提出

2012年8月1日

QC基準を満たした最初の提出物

2012年8月6日

最初の投稿 (見積もり)

2012年8月9日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年2月4日

QC基準を満たした最後の更新が送信されました

2013年1月31日

最終確認日

2013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

  • 39952EP

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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