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Completed

NCT Number: NCT04582643

Pilot Test of a Healthy Metabolic Behaviour Tool

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.

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Key information

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

6P intervention

Behavioral

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.

Primary outcomes

  1. Meal portion size

    Time frame: Between 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.

  2. Vegetable intake

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the proportion assessment for vegetable intake in the 6P tool before and after the intervention

  3. Pleasure food intake

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the frequency of pleasure food intake in the 6P tool before and after the intervention

  4. Meal timing

    Time frame: Between 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

  5. Physical activity

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the duration of physical activity in the 6P tool before and after the intervention

  6. Motivational level

    Time frame: Between 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 outcomes

  1. Body weight changes

    Time frame: Between baseline and follow-up visit (1 month)

    Weight changes in kg before and after the intervention

  2. Body mass index changes

    Time frame: Between baseline and follow-up visit (1 month)

    Body mass index changes in kg/m2 before and after the intervention

  3. Dietary behavioral changes

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the Three Factor Eating Questionnaire before and after the intervention

  4. Activity intensity changes

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the International Physical activity Questionnaire

  5. Screen viewing time changes

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the Sedentary Behavioural Questionnaire

Other outcomes

  1. Clarify, usefulness and acceptability of the 6P tool

    Time frame: Follow up visit at 1 month

    Assessed by the feedback evaluation questionnaire

  2. Usefulness and acceptability for the nudges

    Time frame: 1 month

    Assessed by the nudges rating scale and feedback evaluation questionnaire

  3. Other lifestyle changes

    Time frame: Between baseline and follow-up visit (1 month)

    Assessed by the general lifestyle questionnaire

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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