NCT06685432

Brief Summary

The purpose of the study is to evaluate the effect of applying web-based motivational interviewing technique to slightly overweight/obese individuals on individuals' body weight loss and gaining healthy eating habits. Hypotheses:

  1. 1.The rate of decrease in body weight of individuals in the intervention group with motivational interviewing (MI) is higher than the control group.
  2. 2.Individuals in the intervention group with MI show more improvement in healthy eating behaviors than the control group.
  3. 3.The decrease in daily energy and fat intake of individuals in the intervention group with MI is higher than the control group.
  4. 4.The rate of vegetables and fruits in daily food consumption of individuals in the intervention group with MI is higher than the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

November 4, 2024

Last Update Submit

May 6, 2025

Conditions

Keywords

motivational interviewingobesitynutritionweight loss

Outcome Measures

Primary Outcomes (5)

  • Body mass index

    In the study, measurement information was obtained from the participants' own statements. The researcher provided online information to the participants about taking the measurements. The participants were asked to take their body weight (kg) measurements on an empty stomach once a week, at the same time in the morning, making sure to urinate and not drink water before the measurement, and on the same scale except during menstruation. The participants were asked to take their height measurements with a non-stretchable measuring tape, keeping their feet together and barefoot, in the Frankfort plane (eye and earlobe at the same level). The researcher then calculated the body mass index (kg/m2) by dividing the body weight by the square of the height.

    From enrollment to the end of treatment at 12 weeks

  • Waist/hip circumference ratio

    Waist circumference measurements were requested to be taken from the midpoint between the last rib and the iliac crest using a flexible, non-elastic tape measure with a precision of 0.1 cm. When measuring hip circumference, the arms were hung to the sides, the legs were together, and the measurement was made with a non-flexible tape measure positioned under the iliac crest and on the hip at the widest part. The participant was asked to measure with the non-flexible tape measure parallel to the floor during the measurement. Waist/hip ratios \[waist circumference (cm)/hip circumference (cm)\] provide information about the participants' obesity types (gynoid or android). According to the World Health Organization data, a value of ≥ 0.85 cm in women is considered a health risk.

    From start the end of 12 weeks

  • Results of Individuals According to Healthy Lifestyle Scale II (HLBS II)

    The scale developed by Walker et al. measures the health-enhancing behaviors of the individual in relation to a healthy lifestyle. The scale is a questionnaire form consisting of subgroups. The subgroups are self-actualization, health responsibility, exercise, nutrition, interpersonal support and stress management. The validity and reliability study in Turkey was conducted by Bahar. The Crobach alpha internal consistency coefficient for the total HLBS was found to be 0.91. Each subgroup can be used independently. The score of the entire scale gives the healthy lifestyle behavior score. The lowest total score obtained from the scale is 52, and the highest total score is 208. As the total score increases, it is accepted that the individual has more healthy lifestyle behaviors.

    From enrollment to the end of treatment at 12 weeks

  • Results of food consumption frequency

    Participants were asked to fill out a food consumption frequency form including frequency and quantity in the last three months before and after the study. Food consumption frequency includes the basic food groups and the nutrients contained in these groups, namely milk and dairy products, meat and meat products, eggs, legumes, vegetables and fruits, oilseeds, bread and cereals, oil-sugar-sweets, other foods (sauces and ready meals) and beverages. For each of these foods, the expressions "every meal", "every day", "1-2 times a week", "3-4 times a week", "5-6 times a week", "2-3 times a month", "once a month or less" were used and consumption quantities were questioned. The amounts of food and beverages consumed were multiplied by "1" for "every day", "0.7855" for "5-6 times a week", "0.498" for "3-4 times a week", "0.2145" for "1-2 times a week", "0.067" for "every 15 days", and "0.033" for "once a month" to determine the average daily amounts.

    From enrollment to the end of treatment at 12 weeks

  • Results of food consumption records (24 hour)

    In the study, participants' food consumption records were taken every week for three days before and during the study. In order to better analyze the data collected during the study, the food consumption record data taken before the study was averaged for each of the two weeks; 12 weeks were evaluated as 6 time periods. Accordingly, in the study that lasted a total of 12 weeks, excluding the pre-study period, the 1st and 2nd weeks (time 1), 3rd and 4th weeks (time 2), 5th and 6th weeks (time 3), 7th and 8th weeks (time 4), 9th and 10th weeks (time 5), 11th and 12th weeks (time 6) were evaluated together.The evaluation of the participants' daily energy and nutrient intake was made using the Nutrition Information System (BeBIS) 9.0 computer package program. The nutrient values calculated through this program were evaluated according to the Turkey-Specific Nutrition Guide according to gender and age.

    From enrollment to the end of treatment at 12 weeks

Study Arms (1)

intervention

EXPERIMENTAL
Behavioral: Diet

Interventions

DietBEHAVIORAL

The effect of motivational interviewing techniques was examined in addition to diet treatment. The effect of motivational interviewing techniques on anthropometric measurements before and after the study was evaluated. The participants' indecisiveness was investigated and a self-directed "change conversation" was presented. Behavior change strategies including determining positive and negative aspects, using importance and confidence scales, and setting the agenda were applied by the researcher. In the interviews that included motivational interviewing techniques: 1. A participant-centered interview was conducted by collaborating with the participant. 2. The researcher was impartial and did not assume the role of an expert. 3. At the beginning of the interview, an evaluation of what was discussed in the previous week was made. 4. First of all, an attempt was made to determine the agenda according to the topic the participant wanted to discuss. 5. The importance scale was used (1-10).

Also known as: motivational interviewing
intervention

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gender : Female,
  • Between 19-50 years of age,
  • BMI ≥25.0 kg/m2,
  • No condition that would prevent movement,
  • No chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
  • Individuals who signed the consent form and agreed to participate in the study were included.

You may not qualify if:

  • Pregnant or planning to become pregnant,
  • Menopausal,
  • Breastfeeding,
  • Chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
  • History of eating disorders,
  • Not simultaneously following another nutrition counseling program,
  • History of bariatric surgery,
  • Using medications that affect body weight control,
  • Abusing drugs and alcohol,
  • Having voluntary vomiting behavior more than once a month,
  • Purgative habits (use of laxatives, diuretics, etc.),
  • On a special diet,
  • Gender :Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman Unıversity

Muğla, Fethiye, 48300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Weight LossObesity

Interventions

DietMotivational Interviewing

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • SİBEL ERDEM, LECTURER

    university

    PRINCIPAL INVESTIGATOR
  • PELİN BİLGİÇ, ASSOC. PROF.

    university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
A total of 352 individuals who wanted to participate in the study were interviewed and informed about the study by phone. After the evaluation of the inclusion and exclusion criteria, preliminary data were collected from 172 individuals. The individuals included in the study were first stratified according to their BMI classes (25.0-29.9 kg/m2 slightly overweight and ≥30 kg/m2 obese). Then, the BMI classes were divided into the intervention and control groups in a balanced manner using the block randomization method. Randomization lists within each stratum were created with the help of the PASS software 11.0 (NCSS LLC, Kaysville, UT) using the "Random sorting randomization algorithm" (Maximum Permissible Deviation = 10%). In total, equal numbers of participants were randomly assigned to the experimental and control groups.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study included a control group and an intervention group. All participants received medical nutrition therapy. Also, participants in one intervention group were exposed to motivational interviewing techniques for weight loss. The daily energy needs of the participants in the Medical Nutrition Program were calculated using the basal metabolic rate obtained with the Harris Benedict equation and the PAL (Physical activity level) value obtained from the average of three-day physical activity records (Total Energy Expenditure = BMR x PAL). In the study, a program was prepared in such a way that the daily energy intake of the participants in the nutritional treatment would provide a weight loss of 0.5-1 kg per week. Accordingly, it was aimed to reduce the participant's daily energy intake by approximately 500-600 kcal and provide a 10% kcal decrease in their body weight. A diet program containing 45-60% carbohydrate, 10-20% protein and 20-35% fat in the daily energy needs was applied.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 12, 2024

Study Start

August 20, 2021

Primary Completion

November 20, 2022

Study Completion

January 1, 2023

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations