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Motivational Interviews Based on the Five-Step (5A) Model on Obesity Risk

12. august 2026 opdateret af: Simay Hiçyılmaz, Istinye University

The Effect of Structured Motivational Interviews Based on the Five-Step (5A) Model on Behavioral Change in Individuals at High Risk of Obesity in Family Medicine: A Mixed-Methods Randomized Controlled Trial Study Protocol

The goal of this clinical trial is to learn if a structured motivational interviewing program based on the Five-Step (5A) model works to promote healthy lifestyle behaviors in individuals at high risk of obesity. It will also learn about the effects on anthropometric measurements and physical activity levels. The main questions it aims to answer are:

  • Does this structured program promote healthy lifestyle behaviors in individuals at high risk of obesity?
  • To what extent does it increase participants' intrinsic motivation and readiness for behavioral change?

Participants will:

  • Attend structured interview sessions throughout the designated process
  • Visit the clinic at regular intervals for follow-up and evaluations
  • Record their lifestyle changes, physical activity levels, and experiences throughout the process

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Ümraniye
      • Istanbul, Ümraniye, Tyrkiet (Türkiye)
        • Ümraniye No.19 Family Health Center
        • Ledende efterforsker:
          • Simay Hiçyılmaz, MD, PhD Candidate

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged:18-64 years,
  • Body Mass Index (BMI): 25.0-35.0 kg/m² (Overweight or Class I Obesity)
  • Literate,
  • Voluntary agreement to participate.

Exclusion Criteria:

  • Body Mass Index (BMI): >35.0 kg/m²,
  • Active involvement in a concurrent weight loss program,
  • Current use of anti-obesity medication,
  • Severe psychiatric or cognitive disorders,
  • Pregnancy,
  • Missing more than one motivational interview session,
  • Orthopedic conditions precluding physical activity.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Group
Experimental Group: Participants receive five structured motivational interviewing sessions over a three-month intervention period, with anthropometric measurements repeated at each session.
Adfærdsmæssigt: Motivational Interviewing
Motivational Interviewing Techniques and the Five-Step (5A) Model Framework
Ingen indgriben: Control Group
Control Group: Participants are monitored with standard routine care over a three-month intervention period without motivational interviewing sessions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: Until the end of five motivational interviews that will take place over a three-month period
Changes in body mass index measured in kg/m² from baseline to the end of the intervention period.
Until the end of five motivational interviews that will take place over a three-month period
Change in Body Weight
Tidsramme: Until the end of five motivational interviews that will take place over a three-month period
Changes in body weight measured in kilograms (kg) from baseline to the end of the intervention period.
Until the end of five motivational interviews that will take place over a three-month period
Change in Waist Circumference
Tidsramme: Until the end of five motivational interviews that will take place over a three-month period
Changes in waist circumference measured in centimeters (cm) from baseline to the end of the intervention period.
Until the end of five motivational interviews that will take place over a three-month period
University of Rhode Island Change Assessment (URICA) Scale Score
Tidsramme: Until the end of five motivational interviews that will take place over a three-month period
Changes in readiness score measured by the 32-item University of Rhode Island Change Assessment (URICA) scale. Each item is rated on a 5-point Likert scale ranging from 1 to 5, where higher scores indicate greater readiness for change.
Until the end of five motivational interviews that will take place over a three-month period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Physical Activity Level
Tidsramme: Until the end of five motivational interviews that will take place over a three-month period.
Changes in physical activity levels measured by the General Practice Physical Activity Questionnaire (GPPAQ) instrument from baseline to the end of the intervention period, categorizing participants into four activity levels (active, moderately active, moderately inactive, and inactive) based on occupational physical activity and exercise/cycling hours.
Until the end of five motivational interviews that will take place over a three-month period.
Qualitative Assessment of Motivational Factors
Tidsramme: Until the end of five motivational interviews that will take place over a three-month period.
Qualitative themes encompassing awareness, motivational barriers, health responsibility, and self-efficacy assessed via in-depth interviews.
Until the end of five motivational interviews that will take place over a three-month period.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istinye University

Efterforskere

  • Studieleder: Gülhan Kalmuk, Assist. Prof. Dr., Istinye University
  • Ledende efterforsker: Simay Hiçyılmaz, MD, PhD Candidate, Istinye University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

9. august 2026

Først indsendt, der opfyldte QC-kriterier

12. august 2026

Først opslået (Faktiske)

18. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-249

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The datasets generated and/or analyzed during the current study will not be publicly available due to participant privacy but will be available from the corresponding author on reasonable request after the publication of the main trial results. De-identified participant data will be shared subject to approval.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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