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A Trial of One to One Weight Management in Primary Care

A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00891943
Enrollment
380
Registered
2009-05-01
Start date
2009-06-30
Completion date
2010-12-31
Last updated
2010-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Obesity, Overweight, Randomised controlled trial, Primary Care, Weight, Cardiovascular Risk, Diabetes, Quality of life

Brief summary

The purpose of this study is to conduct a randomised controlled trial to assess the sustained effects on weight, selected risk factors and sense of well-being of offering individualized weight management advice in the primary care setting to patients who wish to lose weight; and to identify the key factors influencing the success of the intervention.

Detailed description

Primary care could make a substantial impact on the increasing prevalence of overweight and obesity and their associated adverse impact on health. The lack of a proven intervention may deter health professionals in primary care from providing support to their overweight patients as few obese people recall receiving weight control advice from a health professional. In this study we aim to conduct a large scale randomised controlled trial to assess the effectiveness of a longer-term structured lifestyle support programme provided by a research nurse and the provision of pedometers compared to usual care in overweight/ obese adults who wish to lose weight. We will assess the degree of weight loss over a period of 12 months as well as related factors such as changes in waist circumference, quality of life and cost-effectiveness of the interventions. The research is highly relevant to policy making at both national and local levels.

Interventions

OTHERStructured lifestyle support

The intervention group will meet with a research nurse on 14 occasions over the 1 year research study, for structured lifestyle support, including dietary, physical activity and behavioral advice. They will also receive a pedometer.

Sponsors

NHS Camden
CollaboratorOTHER_GOV
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years or over * BMI ≥ 25 kg/m2 * GP confirmation

Exclusion criteria

* pregnant or lactating women * patients with renal failure, pacemakers or cancer * participating in other research affecting weight * Ability to complete questionnaires * Ability to give consent

Design outcomes

Primary

MeasureTime frame
Changes in weight, waist circumference and percent body fat at 12 months.12 months

Secondary

MeasureTime frame
Weight, waist circumference, and percent body fat at 6 months.0 and 6 months
BMI, blood pressure, resting heart rate; obesity and weight related quality of life, Rosenberg measure of self-esteem changes at 12 months.0 and 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026