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

12. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Ümraniye
      • Istanbul, Ümraniye, Tyrkia (Türkiye)
        • Ümraniye No.19 Family Health Center
        • Hovedetterforsker:
          • Simay Hiçyılmaz, MD, PhD Candidate

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Istinye University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

9. august 2026

Først innsendt som oppfylte QC-kriteriene

12. august 2026

Først lagt ut (Faktiske)

18. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-249

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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