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Cities for Better Health Childhood Obesity Prevention Initiative

Study acronym: CBH COPI
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2027 → Dec 31, 2028
See other at-risk trials from Novo Nordisk

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 31, 2027 to Dec 31, 2028
    • Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv11
  3. Study sites revised (6)v10
  4. Trial status: Recruiting to Enrolling by Invitation
    • Study sites revised (6)
    v9
  5. Phase: Not specified to Not applicablev8 Show 6 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 5 to 6
    • Interventions: No treatment given (Other) to Community-based intervention packages (Behavioral)
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints expanded, about 9 words
    • Study description expanded, about 312 words
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 4 to 5v7
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 29, 2025 to Apr 30, 2025
    v6
  3. Start date: Apr 22, 2025 to Apr 29, 2025
    • Study sites revised (4)
    v5
  4. Study sites: 3 to 4v4
  5. Start date: Mar 3, 2025 to Apr 22, 2025v3
  6. Enrollment target: 12000 to 36000
    • Study sites: 6 to 3
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
268 trials monitored
See 15 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
This research project is part of the 'Cities for Better Health Childhood Obesity Prevention Initiative' (CBH COPI). The objective of the CBH COPI initiative is to develop, implement, and evaluate the effectiveness of a package of prevention interventions in five cities to promote healthy eating, physical activity, a positive health-related quality of life, and a reduction in rates living with overweight or obesity among children aged 6-13 years in six cities across Australia, Brazil, Canada, Japan, South Africa and Spain. The primary research objective of CBH COPI is to estimate the impact of the intervention packages on the average BMI of the target population of children across the participating countries, at one-year and two-year follow-ups. The secondary research objective is to estimate the impact of the intervention packages on average health-related quality of life (HRQoL) at the same time points. Exploratory aims include estimating the impact of the packages on behaviours related to physical activity and diet.
Trial Details
NCT Number NCT06855563
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 36,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov