- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01736111
Text Messaging for Weight Loss
Text Messaging for Weight Loss in Primary Care Patients
Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive usual medical care, printed materials, and educational text messages. The INTERVENTION group will also receive personalized coaching and feedback, as well as peer support, via text message.
The investigators hypothesize that compared to those in the Control group, patients in the Intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- UT Physicians - Internal Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Approved to participate by PCP (Patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their PCP)
- Age ≥ 21 years
- Body mass index (BMI) 25 to 45 kg/m2 and weight ≤ 400 pounds
- Goal of losing weight (not just maintain weight)
- Willing to change diet, physical activity in order to lose weight.
- Currently uses text messaging in English on mobile phone
- Willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided)
- Have a scale at home for self-monitoring weight
- Fluent in English (speak, read, write)
- Commit to return for follow-up weight at 6 months regardless of amount of weight lost
Exclusion Criteria:
- Involuntary or voluntary weight loss of ≥ 5% body weight in previous 6 months
- Participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months
Any of the following medical conditions which could affect weight or for which weight loss is contraindicated
- End-stage liver disease
- End-stage kidney disease
- Cancer within previous 2 years (except non-melanoma skin cancer)
- Myocardial infarction, stroke, or transient ischemic attack within previous 6 months
- Unstable angina
- Severe arthritis or other medical conditions which would prevent brisk walking
- Schizophrenia
- Hospitalization for psychiatric problems during the prior 12 months.
Current use or anticipated future use (during 6 month study) of medications that could cause weight loss:
- phentermine
- orlistat (prescription Xenical or OTC Alli)
- topiramate
- buprioprion
- exenatide (Byetta)
- liraglutide (Victoza)
- Prior bariatric surgery or plans for bariatric surgery in next 6 months
- Pregnant or breast feeding within the previous 6 months
- Planning to become pregnant in next 6 months
- Consumes > 14 alcoholic drinks per week
- Current use of illicit drugs
- Planning to move out of the area in the next 6 months
- Another member of household or a close contact is participating in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Personal feedback
This arm will receive all intervention components of Active Comparator group, plus the following:
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활성 비교기: One Way Text
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in weight from baseline
기간: baseline and 6 months
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Weight in a lightweight hospital gown with no shoes (calibrated digital scale)
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baseline and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in diet measured by Fruit and Vegetable Screener (NCI)
기간: baseline and 6 months
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baseline and 6 months
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Change in physical activity as measured by Paffenbarger physical activity questionnaire
기간: baseline and 6 months
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baseline and 6 months
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Change in social support as measured by Weight Management Support Inventory
기간: baseline and 6 months
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A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal)
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baseline and 6 months
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Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
기간: baseline and 6 months
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Measures the individual's self-rated executive functioning.
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baseline and 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kevin O. Hwang, MD, The University of Texas Health Science Center, Houston
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Personal feedback에 대한 임상 시험
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Istituto Ortopedico Galeazzi모병수술 후 혈종, 고관절 치환술, 수술이탈리아
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Memorial Sloan Kettering Cancer Center모병
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Xuanwu Hospital, Beijingthe Alberto Santos Dumont Association for Research Support알려지지 않은