Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose (CTL)
2016年3月31日 更新者：Charles B. Eaton、Memorial Hospital of Rhode Island
Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice
The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study.
It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort.
The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective.
The cost of intervention will be evaluated as it relates to study replication.
調査の概要
詳細な説明
The study will translate and evaluate previously successful weight loss and physical activity studies into a primary care setting in terms of efficacy and cost effectiveness.
Patients are recruited by their primary care physicians office and screened for participation and contraindications by phone.
A screening visit with a run-in period of food and exercise log adherence is performed.
All participants have meetings with a Lifestyle Counselor to set nutritional and lifestyle goals and an introduction to weight loss techniques at baseline, 6 months, and 12 months.
A structured eating plan will be given at the baseline visit.
Participants at the baseline visit are randomized to either the intervention and control groups.
During the first year, intervention participants will receive monthly motivational phone calls from their lifestyle counselor to assess their progress and help navigate the lifestyle changes.
Food and exercise logs are reviewed frequently and written feedback give to each interventional participant.
Intervention participants also receive weekly mailings focusing on weight loss, physical activity and healthy eating, and four tailored mailings based upon information gained through contact with the lifestyle counselor.
Intervention participants will also receive 2 informative DVDs during the first year.
Control participants receive 2 NIDDK informational handouts on weight loss.
For the second year of the study focuses on maintenance.
Intervention participants receive reduced mailings of 2 per month for 6 months and then once a month until the end of one year.
Intervention participants receive one additional motivational phone call at 13 months if they have not reached their weight loss goal and also receive 2 more informative DVDs.
The control participants will receive 3 informational NIDDK mailings.
The two arms of the study will be compared using the critical outcome measures (weight loss, PA, fat calories & vegetable/fruit servings consumed) and secondary outcome measures (waist and hip circumference,BP,Heart rate) for weight loss efficacy.
We will also evaluate the cost-effectiveness for dissemination as a PCP weight loss program in addition to the overall cost-effectiveness for the participant in terms of money spent and adverse events related to the lifestyle change.
研究の種類
介入
入学 (実際)
200
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
-
-
Rhode Island
-
Pawtucket、Rhode Island、アメリカ、02816'
- Memorial Hospital of Rhode Island
-
-
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～80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:
- Male/female ≥18 and <80 years old
- Available for this research project for the entire 24-month study period
- Able to read and speak English
- Can provide informed consent
Exclusion Criteria:
- Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
- Unstable psychiatric condition
- History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
- Limited physical activity by a physician to less than a brisk walk
- Another family member in the study
- Limited prescribed diet (e.g. gluten free diet)
- Present treatment for an eating disorder
- Underwent treatment for cancer in the past 5 years
- Dialysis
- Poorly controlled diabetes (HgbA1c > 10) or hospitalized in past 6 months for poorly controlled diabetes
- Chronic steroid therapy
- Participant requesting surgical treatment of obesity or weighing over 400 lbs.
- Major surgery in the past month
- Participating in another clinical trial with regards to obesity or physical activity
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
Lifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months.
Maintenance mailings biweekly for six months and then monthly during the second year.
|
|
|
プラセボコンパレーター：Control
Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.
|
|
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 |
|---|---|---|
|
Changes in Body Weight & Physical Activity
時間枠：Five years
|
The primary outcomes of the trial are measured changes in BMI and physical activity level.
|
Five years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cost Effectiveness
時間枠：Five Years
|
Secondary outcomes are cost effectiveness of the intervention as measured by cost per unit of BMI loss.
Additional outcomes are changes in stages of change, decision balance, self-efficacy, and problem solving skills during the trial.
|
Five Years
|
|
Eating Behaviors
時間枠：5 years
|
Eating behaviors (measured as servings of fruits/vegtables and fat calories consumed) as self reported, Diet History Questionnaire II, SF-12, Eating Behavior Inventory, Three Factor Eating, and General Self Efficacy questionnaires
|
5 years
|
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：Charles B Eaton, MD、Memorial Hospital of Rhode Island
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
2009年9月1日
一次修了 (実際)
2014年7月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2012年2月27日
QC基準を満たした最初の提出物
2012年3月1日
最初の投稿 (見積もり)
2012年3月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年4月4日
QC基準を満たした最後の更新が送信されました
2016年3月31日
最終確認日
2016年3月1日
詳しくは
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。