- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Javeria Mansoor, MBBS
- Numéro de téléphone: +922134864857 +922134864857
- E-mail: javeriaresearcher@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Hanna K Tunio, MBBS, MPhil, MHPM
- Numéro de téléphone: +922134864933
- E-mail: hanna.tunio@aku.edu
Lieux d'étude
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Sindh
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Karachi, Sindh, Pakistan, 75300
- The Aga Khan University
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Contact:
- Javeria Mansoor
- Numéro de téléphone: 03232099788
- E-mail: javeriaresearcher@gmail.com
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Chercheur principal:
- Asad Ali
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
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Aucune intervention: Control
This arm will be observed only |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mindful Eating Score
Délai: 4 weeks
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-regulation for eating habits
Délai: 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
|
|
Dietary diversity scores
Délai: 4 weeks
|
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
|
|
Calorie intake from the healthy vs unhealthy food groups.
Délai: 4 weeks
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SWOT analysis
Délai: 4 weeks
|
SWOT (Strengths, Weaknesses, Opportunities, Threats) |
4 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Sanam I Soomro, PhD, Aga Khan University
- Chercheur principal: Syed Asad Ali, MBBS, MPH, DABP, DABPID, Aga Khan University
- Chaise d'étude: Mashaal Shakil, Aga Khan University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-13571-4353
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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