Trials / Completed
CompletedNCT04582643
Pilot Test of a Healthy Metabolic Behaviour Tool
Validation of a Healthy Metabolic Behavior Tool for Overweight and Obese Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- KK Women's and Children's Hospital · Other Government
- Sex
- Female
- Age
- 21 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2020-10-09
- Last updated
- 2021-11-19
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT04582643. Inclusion in this directory is not an endorsement.