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Evaluation of the "Americans in Motion - Healthy Interventions" Project (AIM-HI)

2011년 5월 9일 업데이트: American Academy of Family Physicians

The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health

This research project brings together the American Academy of Family Physicians (AAFP) National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In Motion (AIM). This project will develop and evaluate a practice improvement program to improve family physicians' delivery of effective patient-centered behavior change interventions for "fitness" (physical activity, nutrition and emotional well-being). The investigators seek to develop a unique program that positions fitness in a central role as "the treatment of choice" when dealing with issues of prevention and treatment of chronic conditions. In addition, this newly developed program is intended to help shift the paradigm of family physicians' use of common advice-giving methods to more effective patient-centered lifestyle counseling. Ultimately, this program will seek to improve care for all patients through fitness-related physician interventions.

Outcomes: This study design will allow the investigators to evaluate whether (and how) dissemination of educational materials impacts patient intervention by first engaging clinicians and staff in their personal use of these materials. This project will also evaluate the effects of the behavioral change tools, as well as, the added impact of new physiologic feedback measures (HOMA-IR and NMR Lipoprotein profiles) on physical activity and diet in study participants.

Conclusion: Primary care offices can become more effective settings to help patients improve physical activity, diet and emotional well-being. Demonstrating the value and impact of creating "healthy offices" that endorse and support clinicians, office staff and patients in the use of effective educational materials fits well with the new model of care as part of the AAFP's "Future of Family Medicine" initiatives, which emphasize the importance of lifestyle decisions and supporting successful changes in behaviors within primary care. This project will help define how to accomplish this.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Study Design: This trial will consist of a two-level randomized controlled trial. The first level of randomization will be performed at the practice level in order to study the impact of involving both clinicians and office staff in making their own personal changes (i.e., creating the "healthy" office)- a central component of AIM - on the translation of the project's educational tools to patients. The second level of randomization will occur at the patient level comparing two practice level interventions designed to improve nutrition, increase physical activity and improve emotional well-being. Furthermore, the effectiveness of the educational tools will be evaluated on self-reported diet, physical activity and emotional well-being and established physiologic measures on behavioral change. Both arms of the study will receive brief office-based counseling using established tools that have been compiled for this project. Practices will be asked to work on incorporating brief nutrition, physical activity and emotional well-being messages into routine care - either motivational in nature for people not willing to work on lifestyle changes, or goal-oriented for those working on changes. Patients in the intervention arm will also receive feedback concerning changes in two novel physiologic measures that correlate with improved nutrition and increased physical activity.

연구 유형

중재적

등록 (예상)

950

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Kansas
      • Leawood, Kansas, 미국, 66211
        • American Academy of Family Physicians National Research Network

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age 18 or above
  • BMI greater than or equal to 30
  • Able to participate in moderate physical activity including a 3-minute step test without worsening an existing medical condition
  • Life expectancy of greater than one year
  • Able to read English or Spanish; and
  • Able to be contacted via phone for follow-up with project staff

Exclusion Criteria:

  • Too ill to participate
  • A current diagnosis at the index visit of type 2 diabetes, hyperlipidemia, or coronary heart disease
  • Doctor's evaluation of patient as not appropriate for physical activity
  • Not capable of giving informed consent; and
  • Unable to read English or Spanish, including blindness

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: A, 1, I
Practice-level treatment group
행동: Enhanced Office
Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
활성 비교기: A, 1, II
Practice-level comparison group
행동: Conventional Office
Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
실험적: B, 1, I
Patient-level treatment group
행동: AIM-HI program with enhanced feedback
Patient receives feedback on two novel indicators of their individual cardiovascular risk that: 1)appear to relate to obesity and lack of physical activity, and 2) may show relatively rapid change with improvements in these areas. These are the Homeostatic Assay - Insulin Resistance or HOMA-IR and Nuclear Molecular Resonance (NMR) lipoprotein profiles (NMRLP). These patients and their physicians also will receive periodic feedback on other outcome measures, including BMI, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
활성 비교기: B, 1, II
Patient-level comparison group
행동: AIM-HI program and regular feedback
Patients will not receive feedback on two specific cardiovascular risk indicators (ie, Homeostatic Assay - Insulin Resistance, Nuclear Molecular Resonance lipoprotein profiles). However, patients will receive feedback on Body Mass Index, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Aggregate patient assessment of practice involvement in patient health behaviors
기간: 12 months
12 months
Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
기간: 12 months
12 months
Spread of billing codes for physician fitness counseling
기간: 12 months
12 months
Body Mass Index
기간: baseline, 6, 9, and 12 months
baseline, 6, 9, and 12 months
Homeostatic Assay- Insulin Resistance
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
3-Minute Step Test
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Blood Pressure
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months

2차 결과 측정

결과 측정
기간
Functional health status
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Quality of life and well-being
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to diet
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to physical activity
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining healthy eating
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining physical activity
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining emotional health
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Diet and nutrition related items
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months
Physical activity related items
기간: baseline, 3, 6, 9, and 12 months
baseline, 3, 6, 9, and 12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

American Academy of Family Physicians

협력자

The PepsiCo Foundation

수사관

  • 수석 연구원: Wilson D Pace, MD, FAAFP, American Academy of Family Physicians

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2007년 7월 1일

기본 완료 (실제)

2009년 4월 1일

연구 완료 (실제)

2009년 10월 1일

연구 등록 날짜

최초 제출

2007년 9월 24일

QC 기준을 충족하는 최초 제출

2007년 9월 24일

처음 게시됨 (추정)

2007년 9월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 5월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 5월 9일

마지막으로 확인됨

2011년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 07-034

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. .

신체 활동에 대한 임상 시험

Enhanced Office에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Dominican Republic

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다