Clinical trial NCT06685432: The Effect of Motivational Interviewing on Body Weight and Dietary Habits in Young Adult Women: A Randomized Controlled Study
Official title: The Effect of Motivational Interviewing on Body Weight and Dietary Habits in Young Adult Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obese Women
Keywords: motivational interviewing
obesity
nutrition
weight loss
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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

All participants were interviewed one-on-one in the one-hour intervention group (n=40) and the control group (n=40) for a total of 6 times in two weeks for three months (12 weeks) in a 30-minute video conference environment.

Depending on the participant in the intervention group that received motivational interviews, the interview period was extended if necessary.

Detailed description: Participants were reached by snowball sampling method through an advertisement given on social media of a private diet center in Turkey. Participants were evaluated for suitability by phone interview. All volunteer participants were given detailed information about the study for one hour online. Online informed consent was obtained from participants who agreed to volunteer.

Before and at the end of the study, all participants were asked to fill out the Healthy Lifestyle Behavior Scale (HLBS), Food consumption frequency (which form), International Physical Activity Assessment Questionnaire (IPAQ-short form) and 24-h food consumption record for three consecutive days of the week (2 weekdays and 1 weekend) in an online data environment.

Participants were given portion training using the Turkish Ministry of Health's Turkish Nutrition Guide (TUBER). During the study (12 weeks), participants recorded 24-hour food consumption and physical activity records three days a week. The forms were sent to the researcher via online mail or social media (whatsapp) before the interview. Participants stated their height and were asked to measure their body weight on an empty stomach, without shoes and wearing light clothing, using a scale they used once a week, and their waist and hip circumferences were measured using a non-extensible tape measure.

In addition; the participants in the intervention group were given a medical nutrition treatment program along with motivational interview techniques. The control group was given only a medical nutrition program.

Daily energy needs in both groups were calculated using the Harris Benedict equation and a diet program was prepared to 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, thus achieving a 10% kcal decrease in body weight. The diet program included 45-60% carbohydrates, 10-20% protein and 20-35% fat.

Measures Participant information form: All participants were female. In this study includes questions about marital status, people they live with, health status, use of nutritional supplements, smoking and alcohol use, number of meals, reasons for skipping meals, and whether they received help for weight loss.

Anthropometric measurements: height, waist, hip, body weight measurements were taken by the participant herself at the beginning and end of the study.

Healthy Lifestyle Behavior Scale (HLBS): The scale developed by Walker et al. measures the individual's health-enhancing behaviors related to a healthy lifestyle. The lowest total score obtained from the scale is 52, the highest total score is 208.

Food Consumption Frequency:

For each food, 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 often" were used and the consumption amounts were questioned.

Food consumption record:

International Physical Activity Assessment Questionnaire (IPAQ) Short Form:

It is used to determine the physical activity levels and sedentary lifestyles of adults.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant or planning to become pregnant,
2. Menopausal,
3. Breastfeeding,
4. Chronic disease (e.g. cardiovascular problems, neurological diseases, chronic respiratory diseases, diabetes, etc.)
5. History of eating disorders,
6. Not simultaneously following another nutrition counseling program,
7. History of bariatric surgery,
8. Using medications that affect body weight control,
9. Abusing drugs and alcohol,
10. Having voluntary vomiting behavior more than once a month,
11. Purgative habits (use of laxatives, diuretics, etc.),
12. On a special diet,
13. Getting ≥17 points according to the Beck Depression Inventory or ≥30 points according to the Eating Attitudes Test (EAT) administered before the study were determined as exclusion criteria.
14. Gender :Male

Primary outcomes:
measure: Body mass index
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Waist/hip circumference ratio
timeFrame: From start the end of 12 weeks
measure: Results of Individuals According to Healthy Lifestyle Scale II (HLBS II)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Results of food consumption frequency
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Results of food consumption records (24 hour)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman Unıversity
state: Fethiye
Study officials:
affiliation: university
name: SİBEL ERDEM, LECTURER
role: PRINCIPAL_INVESTIGATOR
affiliation: university
name: PELİN BİLGİÇ, ASSOC. PROF.
role: STUDY_DIRECTOR
References: