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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Lexi Huynh, PhD
- 電話番号:312-996-6615
- メール:activnms@uic.edu
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60612
- University of Illinois Chicago
-
コンタクト:
- Lexi Huynh, PhD
- 電話番号:312-996-6615
- メール:activnms@uic.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし:キャンセル待ち管理
|
|
|
実験的:Treatment
COM-B-based Physical Activity Behavior Intervention
|
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. |
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 |
|---|---|---|
|
Knowledge and Information Provision Questionnaire (NIP)
時間枠:Baseline and week 16
|
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
|
|
Multidimensional Outcome Expectations for Exercise Scale (MOEES)
時間枠:Baseline and week 16
|
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
|
|
Behavioral Intention
時間枠:Baseline and week 16
|
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
|
|
Exercise Goal Setting Scale (EGS)
時間枠:Baseline and week 16
|
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)
|
Baseline and week 16
|
|
Behavioral Regulation Action Planning (BRAP) Subscale
時間枠:Baseline and week 16
|
The BRAP will be administered remotely for capturing the action planning construct.
5 items; Likert scale 1 - 4 (Not true - Completely true)
|
Baseline and week 16
|
|
Behavioral Regulation Action Control (BRAC) Subscale
時間枠:Baseline and week 16
|
The BRAC will be administered remotely for capturing the action control construct.
6 items; Likert scale 1 - 4 (Not true - Completely true)
|
Baseline and week 16
|
|
HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)
時間枠:Baseline and week 16
|
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)
|
Baseline and week 16
|
|
Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)
時間枠:Baseline and week 16
|
The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)
|
Baseline and week 16
|
|
The PA-Related Social Support Scale (PASS)
時間枠:Baseline and week 16
|
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)
|
Baseline and week 16
|
|
The Physical and Social Environment Barriers - Self-developed questionnaire
時間枠:Baseline and week 16
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical Activity Behavior
時間枠:Baseline and week 16
|
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
|
Baseline and week 16
|
|
Physical Activity Behavior
時間枠:Baseline and week 16
|
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
|
Baseline and week 16
|
|
Formative Evaluation
時間枠:Week 16
|
Self-report survey to assess participant satisfaction and collect feedback from participant.
|
Week 16
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Demographic information
時間枠:Baseline
|
Self-report questionnaire will be administered remotely to capture age, sex, race, ethnicity, education, marital status, income
|
Baseline
|
|
Clinical characteristics
時間枠:Baseline and week 16
|
Self-report questionnaire will be administered remotely to capture MS type, disease duration, Patient Determined Disease Steps (PDDS)
|
Baseline and week 16
|
協力者と研究者
捜査官
- 主任研究者:Robert Motl, PhD、University of Illinois at Chicago
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY2026-0787
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。