Impact of Medical Nutrition Therapy and Follow-Up Frequency on Metabolic Syndrome Parameters

NCT ID: NCT06813131

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-14
• Study Completion Date: 2024-07-05

Brief Summary

There is no study that has investigated the effects of medical nutrition therapy and more frequent follow-up via telehealth on metabolic syndrome parameters in patients with MetS who have multiple metabolic disorders such as being overweight, prediabetic/diabetic, dyslipidemic and having increased blood pressure. This study was conducted to examine the effects of medical nutrition therapy and increased follow-up via telephone calls on MetS-related parameters in individuals with MetS.

Conditions

Metabolic Syndrome; Metabolic Syndrome Obesity; Metabolic Syndrome Parameters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Participants in this group attended face-to-face consultations at baseline, and at the 1st, 2nd, and 3rd months (a total of four visits). These sessions focused on providing guidance for dietary and lifestyle modifications.

Group Type: EXPERIMENTAL

Dietary counseling

Intervention Type: OTHER

This intervention uniquely focuses on the frequency of dietitian-led follow-up visits and their impact on metabolic syndrome-related parameters. The study includes three distinct groups with varying levels of follow-up intensity (control, intervention, and intensive intervention).

calling via telephone

Intervention Type: OTHER

The intensive intervention group involves weekly diet adherence assessments via phone calls, setting it apart from other studies that typically rely on less frequent or standardized follow-up schedules. This design allows for the evaluation of how consultation frequency influences outcomes such as weight loss, blood sugar levels, lipid profile, and metabolic syndrome components."

Intensive Intervention

This group followed the same face-to-face consultation schedule as the intervention group (baseline, 1st, 2nd, and 3rd months). In addition, participants were contacted weekly via phone to assess dietary adherence and provide ongoing motivation and support, making this a more frequent and intensive intervention.

Across all groups, the study primarily aimed to evaluate changes in weight loss, blood sugar, lipid levels, and metabolic syndrome parameters, while assessing the impact of intervention intensity on these outcomes.

Group Type: EXPERIMENTAL

Dietary counseling

Intervention Type: OTHER

This intervention uniquely focuses on the frequency of dietitian-led follow-up visits and their impact on metabolic syndrome-related parameters. The study includes three distinct groups with varying levels of follow-up intensity (control, intervention, and intensive intervention).

Control Group

Participants in this group were seen in person only twice, at baseline and at the 3rd month. No additional interventions were applied, and the aim was to observe the natural course of their condition.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary counseling

This intervention uniquely focuses on the frequency of dietitian-led follow-up visits and their impact on metabolic syndrome-related parameters. The study includes three distinct groups with varying levels of follow-up intensity (control, intervention, and intensive intervention).

Intervention Type: OTHER

calling via telephone

The intensive intervention group involves weekly diet adherence assessments via phone calls, setting it apart from other studies that typically rely on less frequent or standardized follow-up schedules. This design allows for the evaluation of how consultation frequency influences outcomes such as weight loss, blood sugar levels, lipid profile, and metabolic syndrome components."

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals with HbA1c values <8.5%
• Diagnosed with MetS by a physician according to the criteria declared by the consensus of the "International Diabetes Federation Task Force on Epidemiology and Prevention, National Heart, Lung, and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society, and International Association for the Study of Obesity" were included.

Exclusion Criteria

• Taking anti diabetic agents other then metformin
• Taking anti hyperlipidemic agents
• Taking anti hypertensive agents
• Using food supplements (w-3, chromium, multivitamins) that could affect metabolic parameters,
• Having kidney failure,
• Having liver failure,
• Having immune failure
• Having chronic gastrointestinal system disease
• Having cancer
• Having type 1 diabetes
• Being pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Kubra Yildiz Guler

Research University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Zujko ME, Rozniata M, Zujko K. Individual Diet Modification Reduces the Metabolic Syndrome in Patients Before Pharmacological Treatment. Nutrients. 2021 Jun 19;13(6):2102. doi: 10.3390/nu13062102.

Reference Type: BACKGROUND

PMID: 34205362 (View on PubMed)

Alfawaz HA, Wani K, Alnaami AM, Al-Saleh Y, Aljohani NJ, Al-Attas OS, Alokail MS, Kumar S, Al-Daghri NM. Effects of Different Dietary and Lifestyle Modification Therapies on Metabolic Syndrome in Prediabetic Arab Patients: A 12-Month Longitudinal Study. Nutrients. 2018 Mar 20;10(3):383. doi: 10.3390/nu10030383.

Reference Type: BACKGROUND

PMID: 29558423 (View on PubMed)

Parker AR, Byham-Gray L, Denmark R, Winkle PJ. The effect of medical nutrition therapy by a registered dietitian nutritionist in patients with prediabetes participating in a randomized controlled clinical research trial. J Acad Nutr Diet. 2014 Nov;114(11):1739-48. doi: 10.1016/j.jand.2014.07.020. Epub 2014 Sep 11.

Reference Type: BACKGROUND

PMID: 25218597 (View on PubMed)

Other Identifiers

HU-BVD-KYG-01

Identifier Type: -

Identifier Source: org_study_id