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

NCT06813131 | Completed DMC

• 1 other identifier: HU-BVD-KYG-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Keywords

metabolic syndrome x; abdominal obesity; medical nutrition therapy

Outcome Measures

Primary Outcomes (1)

• waist circumference

  Waist circumference, which is an indicator of abdominal obesity, the central component of metabolic syndrome, was determined as the primary outcome because of its strong association with cardiometabolic risk and its correlation with other MetS components, and because it is a significant measure in reflecting the overall effect of the intervention.

  Baseline, 1 month, 2 months, and 3 months after the start of the intervention

Secondary Outcomes (1)

• fasting plasma glucose, triglyceride, HDL-C and blood pressure (Number of metabolic syndrome criteria)

  Baseline, 1 month, 2 months, and 3 months after the start of the intervention

Study Arms (3)

Intervention Group

EXPERIMENTAL

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.

Other: Dietary counseling; Other: calling via telephone

Intensive Intervention

EXPERIMENTAL

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.

Other: Dietary counseling

Control Group

NO INTERVENTION

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.

Interventions

Dietary counseling 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).

Intensive Intervention; Intervention Group

calling via telephone 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."

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 34205362 BACKGROUND

• 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.

  PMID: 29558423 BACKGROUND

• 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.

  PMID: 25218597 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Obesity, Abdominal

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research University

Model Details: Three groups: Intervention group, Intensive intervention group, Control group

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 6, 2025
• Study Start: October 14, 2023
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

TU (1)