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

Hacettepe University

Status: Completed

Conditions: Metabolic Syndrome Parameters; Metabolic Syndrome Obesity; Metabolic Syndrome

Treatments: Other: Dietary counseling; Other: calling via telephone

Study type: Interventional

Funder types: Other

Identifiers

NCT06813131

HU-BVD-KYG-01

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: calling via telephone

Other: Dietary counseling

Intensive Intervention

Experimental group

Description:

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.

Treatment:

Other: Dietary counseling

Control Group

No Intervention group

Description:

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.