Ramadan Nutrition Plan (RNP) Education for Glycaemic Control in Older Adults With Type 2 Diabetes in Yogyakarta

NCT07932210, Not applicable, Not yet recruiting, Universiti Putra Malaysia

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Ramadan Nutrition Plan (RNP) Education for Glycaemic Control in Older Adults With Type 2 Diabetes in Yogyakarta	ClinicalTrials.gov
NCT number	NCT07932210	ClinicalTrials.gov
Status	Not yet recruiting	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	133 participants, estimated	ClinicalTrials.gov
Lead sponsor	Universiti Putra Malaysia	ClinicalTrials.gov
Conditions	T2DM (Type 2 Diabetes Mellitus), Ramadan Fasting	ClinicalTrials.gov
Interventions	Ramadan Nutrition Plan (RNP), RNP Printed guidebook, Self-monitoring of blood glucose (SMBG), Standard Care (in control arm), Printed Leaflet Standard Care	ClinicalTrials.gov
First posted	2026-11-12	ClinicalTrials.gov
Last updated	2026-11-12	ClinicalTrials.gov

Registered outcomes 14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Changes in Hemoglobin A1c (HbA1C)	12 week	HbA1c is the percentage of hemoglobin in red blood cells that is bound to glucose. It reflects average blood glucose over the previous 2 to 3 months. It was measured from a venous blood sample using the AFIAS analyzer at two point times, baseline of the intervention (week 0) and the end of the intervention (week 12). A higher percentage indicates poorer glycemic control and a lower percentages indicates better control.	ClinicalTrials.gov
Secondary	Changes and Differences of Macronutrients Intake	12 week	Macronutrients intake was calculated from a three-days food record completed by each participant. It covers energy, protein, fat, and carbohydrate intake. Energy is reported in kilocalories (kcal), protein, fat, and carbohydrate in grams (g). Each macronutrient also reported as a percentage of total energy intake. Mean intake was compared within each group over time to assess change and between the intervention and control group to assess differences. Data was collected at three times point baseline of the intervention (week 0), middle of intervention (week 8), and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Changes in Body Weight	12 week	Body weight was measured in kilograms (kg) with a digital scale, with the participant standing. The change was calculated as the different between baseline of the intervention (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Changes in Body Mass Index (BMI)	12 week	Body Mass Index is the ratio of the subject weight in kilograms divided by the square of their height in meters (kg/m2). The change in BMI is calculated as the difference between baseline of the intervention (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Changes in Waist Circumference	12 week	Waist circumference is a simple physical measurement taken using a measuring tape (metline) around the abdomen (midpoint between the lowest rib and the iliac crest) and reported in centimeters (cm). It is used to estimate central obesity. The change in waist circumference is calculated as the different between the waist circumference value at the baseline of the intervention (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Changes in Hand Grip Strength	12 week	Hand grip strength was measured with a hand grip dynamometer and reported as kilograms (kg). The changes was calculated as the different between the baseline of the intervention (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Changes in Systolic Blood Pressure	12 week	Systolic blood pressure was measured by registered nurse using a sphygmomanometer and reported in millimeters of mercury (mmHg). The changes was calculated as the different between the baseline of the intervention (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Changes in Diastolic Blood Pressure	12 week	Diastolic blood pressure was measured by registered nurse using a sphygmomanometer and reported in millimeters of mercury (mmHg). The changes was calculated as the different between the baseline of the intervention (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Secondary	Different Fasting blood glucose between group	week 6 and week 8 after the start of intervention	Fasting blood glucose was measure from a capillary blood sample after 10 hours of fasting and reported in mg/dL. It was measured twice, at week 6 and week 8 of intervention. Mean blood glucose was compared between the control group and the intervention group at each time point.	ClinicalTrials.gov
Secondary	Proportion of participants with hypoglycemia and hyperglycemia by group	week 6 and week 8 after the start of intervention	Fasting blood glucose was measured from a capillary blood sample taken after 10 hours of fasting and reported in mg/dL. Participants were classified into three categories based on their fasting blood glucose: hypoglycemia (below 70 mg/dL), normal (70 to 125 mg/dL), and hyperglycemia (above 125 mg/dL). The number and percentage of participants in each category were compared between the intervention group and the control group at each time point.	ClinicalTrials.gov
Secondary	Changes in Knowledge	12 week	Knowledge about the RNP was measured with questionnaire based on the structured of RNP book. The questionnaire has 15 questions. Each question was answered true, false, or do not know. The correct answer score 1 point and an incorrect answer or do not know answer score 0. Total score range from 0 to 15. The changes was calculated as the different between the baseline before education session (week 0) and the end of the intervention (week 12).	ClinicalTrials.gov
Other	Reach	12 week	Reach was the proportion of invited participants who attended the intervention sessions. It was taken from the participant attendance log and calculated as the number of participants who attended divided by the number of participants invited, multiplied by 100, and reported as a percentage. Values range from 0% to 100%. Attendance was recorded at four sessions (week 0, week 6, week 8, and week 12).	ClinicalTrials.gov
Other	Dose received of RNP	12 week	Dose received was the extent to which participants read and actively utilized the RNP educational materials and guidelines throughout Ramadan. It was assessed with a self-developed questionnaire completed by participant themselves at the end of the intervention.	ClinicalTrials.gov
Other	Dose Received of SMBG	Week 6 until week 9 after the start of intervention	Dose received of SMBG was the extent to which participants carried out SMBG as instructed in the intervention. It was taken from the SMBG monitoring and evaluation log, which participants completed themselves. Calculated as the number of SMBG measurements recorded in the log divided by the number of measurements recommended, multiplied by 100, and reported as a percentage.	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)