NCT04582643

Pilot Test of a Healthy Metabolic Behaviour Tool

Completed NA Last updated 19 November 2021

What this trial tests

NA trial testing 6P intervention in Metabolic Disease in 50 participants. Completed in 30 September 2021.

Timeline

1 July 2021

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	KK Women's and Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	1 July 2021
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	1 location across Singapore

Drugs / interventions tested

• 6P intervention

Conditions studied

• Metabolic Disease — all drugs for Metabolic Disease →
• Obese — all drugs for Obese →
• Diet Habit — all drugs for Diet Habit →

Sponsor

KK Women's and Children's Hospital

Who can join

Adults 21 to 40, female only, with Metabolic Disease or Obese. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and Validation of a Lifestyle Behavior Tool in Overweight and Obese Women through Qualitative and Quantitative Approaches.
   Ku CW, Loo RSX, Lim CJE, Tan JJX, et al · · 2021 · cited 7× · PMID 34960105 · DOI 10.3390/nu13124553