NCT03212391

Brief Summary

Monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect of diet with or without Nordic Walking on weight loss, physical performance and cardiovascular risk factors in overweight and obese population

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

July 6, 2017

Last Update Submit

July 6, 2017

Conditions

Abdominal ObesityMetabolic SyndromeDisability PhysicalSarcopenic ObesityHypertensionOverweight and ObesityCardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

  • VO2 max

    maximal oxygen consumption

    12 months

Secondary Outcomes (7)

  • VO2 max changes

    3, 6, 9 and 12 months

  • PWV

    3, 6, 9 and 12 months

  • muscle strength

    3, 6, 9 and 12 months

  • fat mass

    3, 6, 9 and 12 months

  • muscle mass

    3, 6, 9 and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Diet+Walking

EXPERIMENTAL

52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking

Behavioral: DietBehavioral: Walking

Diet+Nordic Walking

EXPERIMENTAL

52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking

Behavioral: DietBehavioral: Nordic Walking

Interventions

DietBEHAVIORAL

52 weeks of Diet supervised by a dietician

Diet+Nordic WalkingDiet+Walking
WalkingBEHAVIORAL

26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking

Diet+Walking
Nordic WalkingBEHAVIORAL

26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking

Diet+Nordic Walking

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Males and females
  • BMI \> 27 kg/m2
  • living in Verona (Italy)
  • stable weight in the 3 months
  • not involved in physical exercise programs
  • informed consent sign

You may not qualify if:

  • cardiovascular disease (unstable angina, recent myocardial infarction, cardiac arrhythmias, heart failure, valvular heart disease, aortic aneurysm, recent intracerebral or subdural hemorrhage, not controlled hypertension)
  • musculoskeletal disease (symptomatic discal hernia, symptomatic arthrosis, acute articular, tendon or ligament lesions, hip prothesis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUI Verona

Verona, 37126, Italy

RECRUITING

Related Publications (1)

  • Muollo V, Rossi AP, Milanese C, Zamboni M, Rosa R, Schena F, Pellegrini B. Prolonged unsupervised Nordic walking and walking exercise following six months of supervision in adults with overweight and obesity: A randomised clinical trial. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1247-1256. doi: 10.1016/j.numecd.2020.12.012. Epub 2020 Dec 17.

    PMID: 33549445DERIVED

MeSH Terms

Conditions

Obesity, AbdominalMetabolic SyndromeHypertensionOverweightObesity

Interventions

DietWalkingNordic Walking

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Mauro Zamboni

    AOUI Verona

    STUDY DIRECTOR

Central Study Contacts

Andrea P Rossi, Md PhD

CONTACT

0458122537andrea.rossi@hotmail.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Monocentric unblinded two parallel-group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 11, 2017

Study Start

September 19, 2016

Primary Completion

January 20, 2018

Study Completion

July 20, 2018

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)