Pilot Test of a Healthy Metabolic Behaviour Tool

Metabolic Disease Clinical Trial

Official title:

Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582643
• Other study ID #: CIRB 2020/2530
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to validate and pilot test the short-term intervention effect of a newly developed healthy metabolic behaviour tool, named as the 6P tool, on dietary attitude/ practice and body weight changes over one month among overweight and obese women. A total of 50 women, aged 21-40 years, BMI ≥25 kg/m2, who are attending the preconception clinic and planning for a pregnancy over the next one year, will be invited to participate in this pilot study. The recruitment period is estimated to take up to 10 weeks, with subsequent 1 month follow-up visit.

Description:

Preconception is a stage that could critically influence subsequent antenatal and postnatal health of mother and offspring. In Singapore, approximately one-third of women are overweight and obese during the preconception period. In the present pilot study, the investigators aim to introduce a simple, self-administered tool that can identify discrete components of an individual's diet, which would lead to self-awareness, self-evaluation and self-education, and over time, results in a positive change in eating habits and health. Specifically, the study aims i) to validate a newly developed tool that comprises six main dietary components (6P), namely Portion, Proportion, Pleasure, Phase, Physicality and Psychology in overweight and obese women during the preconception period; (ii) and to assess the short-term intervention effect of the 6P tool on dietary attitude/ practice and body weight changes over one month. The investigators hypothesise that intervention using this 6P tool in overweight and obese women will help them to promote healthy eating behaviours and reduce body weight. This study targets to recruit 50 overweight/ obese preconception women, from KK Women's and Children's Hospital, to evaluate the effectiveness of the tool over one month. Throughout the one month follow up period, nudges in the form of text messages/images related to the 6P goals will be sent to participants through mobile phone. This validated 6P tool is planned to be applied in a preconception targeted intervention cohort in order to build a positive mental model in healthy eating among overweight and obese women, enhancing awareness and belief towards weight management behaviour, and promoting a healthy life cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• age 21-40 years

• body mass index >= 25 kg/m2

Related Conditions & MeSH terms

• Diet Habit
• Metabolic Disease
• Metabolic Diseases
• Obese

Intervention

Behavioral:
• 6P intervention
6P assessment targeting on diet, activity and mentality, along with education provided based on the 6P components. The 6P tool serves the functions to help the women to self-monitor and be aware of their negative lifestyle choices.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clarify, usefulness and acceptability of the 6P tool	Assessed by the feedback evaluation questionnaire	Follow up visit at 1 month
Other	Usefulness and acceptability for the nudges	Assessed by the nudges rating scale and feedback evaluation questionnaire	1 month
Other	Other lifestyle changes	Assessed by the general lifestyle questionnaire	Between baseline and follow-up visit (1 month)
Primary	Meal portion size	Assessed by the portion size rating (scores1-7) in the 6P tool before and after the intervention. Higher score indicates higher portion size.	Between baseline and follow-up visit (1 month)
Primary	Vegetable intake	Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention	Between baseline and follow-up visit (1 month)
Primary	Pleasure food intake	Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention	Between baseline and follow-up visit (1 month)
Primary	Meal timing	Assessed by the percentage of total caloric intake during the day and night in the 6P tool before and after the intervention	Between baseline and follow-up visit (1 month)
Primary	Physical activity	Assessed by the duration of physical activity in the 6P tool before and after the intervention	Between baseline and follow-up visit (1 month)
Primary	Motivational level	Assessed by the rating of motivational level (scores 1-9) in the 6P tool before and after the intervention. Higher score indicates higher motivational level.	Between baseline and follow-up visit (1 month)
Secondary	Body weight changes	Weight changes in kg before and after the intervention	Between baseline and follow-up visit (1 month)
Secondary	Body mass index changes	Body mass index changes in kg/m2 before and after the intervention	Between baseline and follow-up visit (1 month)
Secondary	Dietary behavioral changes	Assessed by the Three Factor Eating Questionnaire before and after the intervention	Between baseline and follow-up visit (1 month)
Secondary	Activity intensity changes	Assessed by the International Physical activity Questionnaire	Between baseline and follow-up visit (1 month)
Secondary	Screen viewing time changes	Assessed by the Sedentary Behavioural Questionnaire	Between baseline and follow-up visit (1 month)