Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults
Effectiveness of Holistic Lifestyle mHealth Intervention for Risk Reduction of Type 2 Diabetes Mellitus in Young Adults: A Randomized Controlled Trial
The goal of this clinical trial (randomized controlled trial) is to examine the effectiveness of a holistic lifestyle mHealth intervention in reducing the risk of type 2 diabetes mellitus.
The study focuses on young adults aged 20-35 years, recruited from public and private universities in Rawalpindi and Islamabad, who meet the defined inclusion criteria.
The main questions it aims to answer are:
Does a holistic lifestyle mHealth intervention significantly reduce the risk of type 2 diabetes ? Does the intervention improve overall health-related quality of life and lifestyle behaviors, including diet, physical activity, and stress management?
연구 개요
상태
상세 설명
Researchers will compare participants receiving the holistic lifestyle mHealth intervention (based on "Eat Well, Move More, Stress Less") with a control group receiving standard care or basic health guidance to see if the intervention leads to greater reduction in diabetes risk and improved health outcomes.
Participants will:
Use a culturally tailored mHealth application designed for the Pakistani context Follow lifestyle recommendations focused on diet, physical activity, and stress management Engage with intervention content based on the three core pillars: Eat Well, Move More, Stress Less Participate in periodic assessments, including health measurements and questionnaires Provide feedback on their experience and adherence to the intervention
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Anmol Ayaz, Phd Scholar
- 전화번호: 923335791127
- 이메일: anmol.ayaz@fjwu.edu.pk
연구 연락처 백업
- 이름: Sajida Naz Dr
- 전화번호: +92 323 5493535
- 이메일: dr.sajida@fjwu.edu.pk
연구 장소
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Punjab Province
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Rawalpindi, Punjab Province, 파키스탄, 46000
- University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Young adults aged between 20-35 years, as defined by the WHO.
- At risk of diabetes based on self-reported family history or lifestyle habits.
- Participants who are willing to engage in the mHealth intervention program.
- Own a smartphone and are familiar with using mobile apps.
- Complete the informed consent process, agreeing to follow the study protocol, including survey completion and health assessment.
Exclusion Criteria:
- Individuals diagnosed with chronic mental or physical illnesses
- Individuals with hearing or vision loss so severe that they could not access the mobile health intervention.
- Pregnant women or women who plan on becoming pregnant during the study.
- Individuals who are already taking part in an equivalent diabetes or health programme.
- Individuals who are not willing to provide consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 개입 그룹
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The main components of the holistic mHealth intervention include the following: nutritional education, promotion of physical activity, sleep education, and behavioral health support.
The integration of these components in mHealth promotes a holistic lifestyle through enhancing overall health-related quality of life.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improved quality of Life
기간: 6-8 weeks
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Measured using a validated tool, the Short Form Health Survey (SF-36), assessed at baseline and post-intervention. The primary endpoint is the difference in mean risk scores between the intervention and control groups. score ≤ 44 indicates weak, 45-63 indicate medium, ≥ 64 indicate good. |
6-8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary outcome measures include changes in blood glucose level
기간: 8 weeks
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Diabetes risk assessment is assessed through RAPID (Risk Assessment of Pakistani Individual for Diabetes) . Changes in blood glucose levels assessd through HbA1c measured in mg/dL at baseline and post-intervention. |
8 weeks
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Food literacy
기간: 8 weeks
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Food literacy measured by using Self-Perceived Food Literacy Scale Short Form Scoing : <30.6 indicates inadequate-limited food literacy; >31 indicates adequate-excellent food literacy.
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8 weeks
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Eating Behavior
기간: 8 weeks
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Eating Behavior measured by using Self-Regulation of Eating Behavior Questionnaire for Adults.
Scoring: <2.8 indicate Low level, 2.8 to 3.6 indicate Medium>3.6High
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8 weeks
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Physical Health
기간: 8 weeks
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weight will be combined to report BMI in kg/m^2.
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8 weeks
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sleep quality
기간: 8 weeks
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Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) Scoring :0 - No sleep difficulties; 5 or higher - Poor sleep quality |
8 weeks
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Psychological Distress
기간: 8 weeks
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Psychological Distress will be measured by using Depression, Anxiety and Stress Scale (DASS-21) Scoring: Depression : 0-9 normal ,14-20 moderate , 28+ severe Anxiety : 8-9 mild , 10-14 moderate Stress: 15-18 mild, 19-25 moderate |
8 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
키워드
기타 연구 ID 번호
- JinnahUW
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-dentified participant data underlying the published results may be made available upon reasonable request. Shared data may include demographic variables, outcome measures, and analyzable datasets relevant to the study objectives.
Data requests may be submitted to the principal investigator. Access will be considered for researchers with methodologically sound proposals and subject to institutional ethical approval and data use agreements.
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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