- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Javeria Mansoor, MBBS
- Telefonnummer: +922134864857 +922134864857
- E-post: javeriaresearcher@gmail.com
Studera Kontakt Backup
- Namn: Hanna K Tunio, MBBS, MPhil, MHPM
- Telefonnummer: +922134864933
- E-post: hanna.tunio@aku.edu
Studieorter
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75300
- The Aga Khan University
-
Kontakt:
- Javeria Mansoor
- Telefonnummer: 03232099788
- E-post: javeriaresearcher@gmail.com
-
Huvudutredare:
- Asad Ali
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Inget ingripande: Control
This arm will be observed only |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mindful Eating Score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-regulation for eating habits
Tidsram: 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
Tidsram: 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.
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
SWOT analysis
Tidsram: 4 weeks
|
SWOT (Strengths, Weaknesses, Opportunities, Threats) |
4 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Sanam I Soomro, PhD, Aga Khan University
- Huvudutredare: Syed Asad Ali, MBBS, MPH, DABP, DABPID, Aga Khan University
- Studiestol: Mashaal Shakil, Aga Khan University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-13571-4353
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .