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Pilot Test of a Healthy Metabolic Behaviour Tool

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04582643
Enrollment
50
Registered
2020-10-09
Start date
2021-07-01
Completion date
2021-09-30
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Habit, Metabolic Disease, Obese

Brief 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.

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.

Interventions

BEHAVIORAL6P 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.

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Single arm pilot test of lifestyle intervention using newly developed tool

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Physical activityBetween baseline and follow-up visit (1 month)Assessed by the duration of physical activity in the 6P tool before and after the intervention
Meal timingBetween baseline and follow-up visit (1 month)Assessed by the percentage of total caloric intake during the day and night in the 6P tool before and after the intervention
Meal portion sizeBetween baseline and follow-up visit (1 month)Assessed by the portion size rating (scores1-7) in the 6P tool before and after the intervention. Higher score indicates higher portion size.
Vegetable intakeBetween baseline and follow-up visit (1 month)Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention
Pleasure food intakeBetween baseline and follow-up visit (1 month)Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention
Motivational levelBetween baseline and follow-up visit (1 month)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.

Secondary

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

Other

MeasureTime frameDescription
Clarify, usefulness and acceptability of the 6P toolFollow up visit at 1 monthAssessed by the feedback evaluation questionnaire
Other lifestyle changesBetween baseline and follow-up visit (1 month)Assessed by the general lifestyle questionnaire
Usefulness and acceptability for the nudges1 monthAssessed by the nudges rating scale and feedback evaluation questionnaire

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026