Physical Activity Intervention for Individuals Newly Diagnosed With MS (ActivNMS)
Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing
The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap.
Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group.
Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Lexi Huynh, PhD
- 전화번호: 312-996-6615
- 이메일: activnms@uic.edu
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois Chicago
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연락하다:
- Lexi Huynh, PhD
- 전화번호: 312-996-6615
- 이메일: activnms@uic.edu
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- aged 18 years or older
- self-reported diagnosis of MS by a neurologist within the past 2 years
- relapse-free for the past 30 days
- ability to speak and read English as the primary language
- internet and e-mail access
- willingness to complete study protocol
- ambulatory without an assistive device (PDDS < 3)
- insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14)
- visual ability and literacy to read newsletter with font size 14 points
- on a stable disease-modifying therapy for 6 months
Exclusion Criteria:
- pregnant
- have an elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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간섭 없음: 대기자 명단 제어
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실험적: Treatment
COM-B-based Physical Activity Behavior Intervention
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Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels. Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity. The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS. The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Knowledge and Information Provision Questionnaire (NIP)
기간: Baseline and week 16
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The Knowledge and Information Provision questionnaire will be administered remotely for self-report assessment of knowledge about physical activity. 3 items; Likert scale 1 - 4 (No - Yes, comprehensively) |
Baseline and week 16
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Multidimensional Outcome Expectations for Exercise Scale (MOEES)
기간: Baseline and week 16
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The MOEES will be administered remotely for self-report assessment of outcome expectations for physical activity/exercise. 15 items; Likert scale 1 - 5 (Strongly disagree - Strongly agree) |
Baseline and week 16
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Behavioral Intention
기간: Baseline and week 16
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The behavioral intention will be administered remotely for physical activity behavioral intentions. 5 items; Likert scale 1- 4 (Not true - Completely true) |
Baseline and week 16
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Exercise Goal Setting Scale (EGS)
기간: Baseline and week 16
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The EGS will be administered remotely to capture goal-setting skills.
It includes 10 items rates on a Likert scale with anchors of 1 (Does not describe) and 5 (Describes completely)
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Baseline and week 16
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Behavioral Regulation Action Planning (BRAP) Subscale
기간: Baseline and week 16
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The BRAP will be administered remotely for capturing the action planning construct.
5 items; Likert scale 1 - 4 (Not true - Completely true)
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Baseline and week 16
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Behavioral Regulation Action Control (BRAC) Subscale
기간: Baseline and week 16
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The BRAC will be administered remotely for capturing the action control construct.
6 items; Likert scale 1 - 4 (Not true - Completely true)
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Baseline and week 16
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HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)
기간: Baseline and week 16
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The Self-efficacy subscales will be administered remotely for capturing the self-efficacy levels in physical activity action, recovery, and maintenance.
9 items; Likert scale 1 - 4 (Not true - Exactly true)
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Baseline and week 16
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Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)
기간: Baseline and week 16
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The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)
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Baseline and week 16
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The PA-Related Social Support Scale (PASS)
기간: Baseline and week 16
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The PA-Related Social Support Scale will be administered remotely for capturing physical activity social support 7 items; Likert scale 1 - 4 (Almost never - Almost always)
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Baseline and week 16
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The Physical and Social Environment Barriers - Self-developed questionnaire
기간: Baseline and week 16
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The Physical and Social Environment Barriers will be administered remotely for capturing barriers in physical and social environment. 9 items; Likert scale 1 - 4 (Is not applicable - Applicable) |
Baseline and week 16
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Activity Behavior
기간: Baseline and week 16
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Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
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Baseline and week 16
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Physical Activity Behavior
기간: Baseline and week 16
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International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
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Baseline and week 16
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Formative Evaluation
기간: Week 16
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Self-report survey to assess participant satisfaction and collect feedback from participant.
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Week 16
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Demographic information
기간: Baseline
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Self-report questionnaire will be administered remotely to capture age, sex, race, ethnicity, education, marital status, income
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Baseline
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Clinical characteristics
기간: Baseline and week 16
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Self-report questionnaire will be administered remotely to capture MS type, disease duration, Patient Determined Disease Steps (PDDS)
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Baseline and week 16
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Robert Motl, PhD, University of Illinois at Chicago
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY2026-0787
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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