- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07859644
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits (NOURISH)
Effect of a Mobile Nutrition Application on Dietary Behaviour Among Adults in a Low- and Middle-Income Country: A Randomized Controlled Trial
The goal of this study is to learn if a nutritional smartphone application can improve the dietary habits in adults.
The main objectives are: To explore if the use of a nutritional mobile application can improve a) mindful eating b) dietary diversity c) self-regulation of eating behavior d) calories consumed from healthy food groups vs unhealthy food groups among adults living in a low and middle income country.
연구 개요
상태
상세 설명
Participants will be assessed for eligibility. Those who are eligible will be randomly assigned to either intervention or control arm. The intervention group will be required to download the "Kalorist" application into their smartphones and will be guided about the activation of the application. The control group will only be observed. Both group will be requested to complete a baseline information survey form about their weight, waist circumference, eating habits (including mindful eating, self-regulation and food frequency questionnaire to measure dietary diversity and calorie intake) and nutrition related goals. After a period of 4 weeks both the groups will be re-assessed using the same survey instrument used previously, for endline information. Results will be compared both pre and post within the same group and intervention vs control group. The intervention group will additionally be requested to provide a user experience information for strength, weakness, opportunities and threat (SWOT) analysis for the application.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Javeria Mansoor, MBBS
- 전화번호: +922134864857 +922134864857
- 이메일: javeriaresearcher@gmail.com
연구 연락처 백업
- 이름: Hanna K Tunio, MBBS, MPhil, MHPM
- 전화번호: +922134864933
- 이메일: hanna.tunio@aku.edu
연구 장소
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Sindh
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Karachi, Sindh, 파키스탄, 75300
- The Aga Khan University
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연락하다:
- Javeria Mansoor
- 전화번호: 03232099788
- 이메일: javeriaresearcher@gmail.com
-
수석 연구원:
- Asad Ali
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults (>18 years old).
- Owns a smartphone with internet access.
- Can navigate the application in English.
- Is willing to improve dietary habits.
Exclusion Criteria:
- Pregnant women.
- Dietitians or nutrition professionals.
- Current use of the same or a similar calorie/diet-tracking application.
- Previous use of the same or a similar calorie/diet-tracking application.
- Current participation in a structured weight-loss or dietary program.
- Major medical conditions requiring a therapeutic diet.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Arm
This arm will be provided a nutritional mobile application. |
Kalorist is a nutrition-coaching platform built for South Asian population (desis) all over the world, delivering the kind of personalized, evidence-based support a client gets working one-on-one with a nutritionist, via a mobile app. It follows an assess-guide-monitor-adjust cycle: participant profile data (age, height, weight, gender) and goals set individualized calorie and macronutrient (carbohydrate, protein, fat) targets; participants log food by description, photo, or search, including local dishes and restaurants. Kal, an AI coach built inside, answers users' questions about their own patterns - why weight has plateaued or spiked, why cravings appear after skipping meals - using research-backed explanations rather than opinions, gives behavior- and habit-based guidance, and offers motivational support on request. Meal plans adapt to actual eating. KalLive gives an instant photo-based calorie/macro breakdown to save or share.
다른 이름들:
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간섭 없음: Control
This arm will be observed only |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mindful Eating Score
기간: 4 weeks
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A validated tool named "Mindful Eating Questionnaire (MEQ)" will be used to obtain the mindful eating scores. 28-item questionnaire with subscales which includes Disinhibition, Awareness, External Cues, Emotional Response, Distraction. The minimum possible score is 1 while maximum score is 4. The higher score means more mindful eating. |
4 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-regulation for eating habits
기간: 4 weeks
|
A validated tool "Self-regulation of Eating Behaviour Questionnaire (SREBQ)" for adults will be used to measure self-regulation scores. This is a 5 item and 5 point likert scale based questionnaire and the score ranges lies between 5 to 25 (min to max). Higher score signify better self regulation. |
4 weeks
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Dietary diversity scores
기간: 4 weeks
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The dietary diversity scores (DDS) will be calculated from the food frequency questionnaire based on 24 food groups pre-defined by the Food and Agriculture organization of the United Nations. Among these the food groups classified as healthy are 10 in total therefore the score range lies between 0 to 10 with higher score meaning better dietary diversity. |
4 weeks
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Calorie intake from the healthy vs unhealthy food groups.
기간: 4 weeks
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The calorie intake will be calculated from the food frequency questionnaire based on 24 food groups categorized as healthy, unhealthy or optional by the Food and Agriculture organization of the United Nations. Higher value = better (greater caloric contribution from healthy food groups). There is no fixed minimum or maximum cut off assigned as this is a continuous measure of dietary adequacy and varies from individual to individual. |
4 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SWOT analysis
기간: 4 weeks
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SWOT (Strengths, Weaknesses, Opportunities, Threats) |
4 weeks
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Sanam I Soomro, PhD, Aga Khan University
- 수석 연구원: Syed Asad Ali, MBBS, MPH, DABP, DABPID, Aga Khan University
- 연구 의자: Mashaal Shakil, Aga Khan University
간행물 및 유용한 링크
일반 간행물
- Kliemann N, Beeken RJ, Wardle J, Johnson F. Development and validation of the Self-Regulation of Eating Behaviour Questionnaire for adults. Int J Behav Nutr Phys Act. 2016 Aug 2;13:87. doi: 10.1186/s12966-016-0414-6.
- Framson C, Kristal AR, Schenk JM, Littman AJ, Zeliadt S, Benitez D. Development and validation of the mindful eating questionnaire. J Am Diet Assoc. 2009 Aug;109(8):1439-44. doi: 10.1016/j.jada.2009.05.006.
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
- 2026-13571-4353
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
As the clinicaltrails.gov does not require sharing IPD, we will not share IPD. If the journals require, we will provide anonymized data only for transparency and replication.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .