Pilot Test of a Healthy Metabolic Behaviour Tool

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

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.

Study Overview

• Status: Completed
• Conditions: Obese; Diet Habit; Metabolic Disease
• Intervention / Treatment: Behavioral: 6P intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age 21-40 years
• body mass index >= 25 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6P intervention; 6P assessment along with education provided based on the 6P components.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight changes	Weight changes in kg before and after the intervention	Between baseline and follow-up visit (1 month)
Body mass index changes	Body mass index changes in kg/m2 before and after the intervention	Between baseline and follow-up visit (1 month)
Dietary behavioral changes	Assessed by the Three Factor Eating Questionnaire before and after the intervention	Between baseline and follow-up visit (1 month)
Activity intensity changes	Assessed by the International Physical activity Questionnaire	Between baseline and follow-up visit (1 month)
Screen viewing time changes	Assessed by the Sedentary Behavioural Questionnaire	Between baseline and follow-up visit (1 month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clarify, usefulness and acceptability of the 6P tool	Assessed by the feedback evaluation questionnaire	Follow up visit at 1 month
Usefulness and acceptability for the nudges	Assessed by the nudges rating scale and feedback evaluation questionnaire	1 month
Other lifestyle changes	Assessed by the general lifestyle questionnaire	Between baseline and follow-up visit (1 month)

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Jerry Kok Yen Chan, PhD, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: CIRB 2020/2530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No