- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07593677
Motivating Activity Through Text Communications - Helping Adults Increase Movement (MATCH AIM)
Motivating Activity Through Text - Comparing Human and AI Messages (MATCH AIM) Trial
The goal of this clinical trial is to compare the effect of different types of text messages on physical activity levels of middle-aged and older adults and to determine whether these messages are effective in adults age 40 and older who are engaging in less than 90 minutes per week of moderate or higher intensity physical activity. The main questions it aims to answer are:
- Which types of motivational messages show the greatest effects on changes in daily step counts in a 3-month precision text messaging intervention?
- What are the effects of personalized text messages on automatic affective evaluations, habit strength (experienced automaticity), exercise identity, working memory capacity, and processing speed?
Participants will:
- Wear a Fitbit activity tracker continuously for 3 months and are encouraged to continue wearing it through 6 months.
- Wear an activPAL activity monitor on their thigh for 7-day assessment periods at the beginning of the study, at 3 months, and at 6 months.
- Complete 3 cognitive assessments ("brain games") per day on their smartphone during the 7-day assessment periods at baseline, 3 months, and 6 months.
- Be asked to set goals to increase their daily steps over the first 3 months of the study.
- Receive up to 4 motivational text messages per day for 3 months to encourage physical activity.
- Keep study-related apps (Fitbit app, AIM app, MetricWire app) open in the background on their smartphone.
- Complete questionnaires at the beginning of the study, at 3 months, and at 6 months
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ann M Mehringer
- 전화번호: 734-647-6050
- 이메일: amehring@umich.edu
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan
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수석 연구원:
- David E Conroy, PhD
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연락하다:
- David E Conroy, PhD
- 전화번호: 734-647-8404
- 이메일: deconroy@umich.edu
-
연락하다:
- Ann M Mehringer
- 전화번호: 734-647-6050
- 이메일: amehring@umich.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Be 40 years of age or older
- Own a smartphone running an Android or iOS operating system
- Have proficiency with the English language
- Be capable of providing informed consent
- Be able to perform moderate physical activity without restrictions
- Be willing to complete the entire 6-month protocol
- Be willing to establish a 12-hour window - beginning no later than 9:45 am and ending no later than 9:45 pm - for receiving text messages.
Exclusion Criteria:
- Residing outside of the continental United States
- Self-reporting 90 minutes or more of moderate-to-vigorous intensity physical activity per week
- contraindications to normal physical activity as identified on the Physical Activity Readiness Questionnaire (PAR-Q)
- Mobility restrictions that interfere with unassisted physical activity
- Being pregnant or planning to become pregnant during the study
- Planning to undergo surgery during the course of the study protocol
- Having a prior diagnosis of Alzheimer's disease or a related dementia
- Evidence of mild cognitive impairment as indicated by a mini-Montreal Cognitive Assessment (MoCA) test score of 12 or higher
- Concurrent participation in another study involving weight loss or physical activity
- Failure to respond to at least 85% of Ecological Momentary Assessment (EMA) prompts during the 7-day qualification phase.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Validated library of text messages
Participants in this arm will receive motivational text messages that have been written and used in previous studies.
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Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
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실험적: Newly created text messages
Participants in this arm will receive motivational text messages that have not been used in previous studies.
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Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Daily Step Count
기간: The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months.
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The primary outcome measure is the average daily step count, which is assessed using a blinded, research-grade activPAL activity monitor, worn on the thigh for a 7-day assessment period.
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The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mechanisms of Behavior Change for Adherence: Habit Strength
기간: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Habit Strength will be assessed using the Behavioral Automaticity Index from the Self-Report Habit Index to measure how automatic the exercise behavior has become.
Scores are calculated as the average item responses and range from 1 to 7 with higher scores reflecting greater experienced automaticity (i.e., stronger habits).
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Mechanisms of Behavior Change for Adherence: Exercise Identity (Reflective)
기간: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Exercise Identity will be assessed using the Exercise Identity Scale to see how much participants view themselves as "exercisers".
Scores are based on the average item response and range from 1 to 7 with higher scores representing a stronger exercise identity.
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
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Mechanisms of Behavior Change for Adherence: Automatic Affective Evaluations
기간: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Automatic Affective Evaluations will be assessed using a Single-Category Implicit Association Test (SCIAT) to assess non-conscious attitudes toward physical activity.
Scores are standardized mean differences of response times between blocks of trials where physical activity is paired with unpleasant attributes and blocks of trials where physical activity is paired with pleasant attributes.
Higher scores indicate more favorable automatic affective evaluations of physical activity.
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
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Ambulatory Cognitive Function: Processing Speed
기간: These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Processing Speed will be assessed with the Mobile Monitoring of Cognitive Change (M2C2) Symbol Search Task.
Scores are based on response times for accurate trials so there is no fixed range for scores.
Shorter response times indicate faster (better) processing speed; longer response times indicate slower (worse) processing speed.
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These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Ambulatory Cognitive Function: Working Memory Capacity
기간: These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
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Working Memory Capacity will be measured using the M2C2 Grid Memory Task.
Scores are based on response accuracy measured as a Euclidean distance score.
Shorter distance scores indicate more working memory capacity; longer distance scores indicate less working memory capacity.
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These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: David E Conroy, PhD, University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HUM00262651
- P30AG086637 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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