An interventional study of 6P intervention in Metabolic Disease, Obese and Diet Habit, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to female participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-19.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Prevention
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.
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.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's enrollment of 50 is close to the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.
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Inclusion Criteria:
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.
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Between baseline and follow-up visit (1 month)
Body weight changes
Weight changes in kg before and after the intervention
Time frame: Between baseline and follow-up visit (1 month)
Body mass index changes
Body mass index changes in kg/m2 before and after the intervention
Time frame: Between baseline and follow-up visit (1 month)
Dietary behavioral changes
Assessed by the Three Factor Eating Questionnaire before and after the intervention
Time frame: Between baseline and follow-up visit (1 month)
Activity intensity changes
Assessed by the International Physical activity Questionnaire
Time frame: Between baseline and follow-up visit (1 month)
Screen viewing time changes
Assessed by the Sedentary Behavioural Questionnaire
Time frame: Between baseline and follow-up visit (1 month)
Clarify, usefulness and acceptability of the 6P tool
Assessed by the feedback evaluation questionnaire
Time frame: Follow up visit at 1 month
Usefulness and acceptability for the nudges
Assessed by the nudges rating scale and feedback evaluation questionnaire
Time frame: 1 month
Other lifestyle changes
Assessed by the general lifestyle questionnaire
Time frame: Between baseline and follow-up visit (1 month)
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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KK Women's and Children's Hospital