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Effects of a lifestyle intervention in patients with Non-Alcoholic Fatty Liver Disease or Hepatitis C

Effects of a lifestyle intervention in patients with Non-Alcoholic Fatty Liver Disease or Hepatitis C

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000992404
Acronym
n/a
Enrollment
164
Registered
2016-07-28
Start date
2004-10-25
Completion date
2007-04-18
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The aim of this study was to assess the effect of a lifestyle intervention based on behaviour change theories on liver enzymes and metabolic abnormalities in patients diagnosed with Non-alcoholic fatty liver disease (NAFLD) or Hepatitis C and not receiving anti-viral therapy. We hypothesised that if successful; such an intervention would reduce the metabolic risk profile of patients and thereby lead to a reduction in the drivers of hepatic steatosis and inflammation.

Interventions

The lifestyle intervention was conducted at Westmead Hospital, Australia from 2004 to 2007 in patients diagnosed with non-alcoholic fatty liver disease. Subjects were randomised at baseline to one of 3 intervention arms (Group A, B or C) or a control group. Group A was a low-intensity intervention consisting of 3 consultations over four weeks (Baseline, 2 and 4 weeks). Group B was a moderate-intensity 10 week consisting of 6 fortnightly consultations (baseline, Weeks 2, 4, 6, 8 and 10). Group

The lifestyle intervention was conducted at Westmead Hospital, Australia from 2004 to 2007 in patients diagnosed with non-alcoholic fatty liver disease. Subjects were randomised at baseline to one of 3 intervention arms (Group A, B or C) or a control group. Group A was a low-intensity intervention consisting of 3 consultations over four weeks (Baseline, 2 and 4 weeks). Group B was a moderate-intensity 10 week consisting of 6 fortnightly consultations (baseline, Weeks 2, 4, 6, 8 and 10). Group C had an identical intervention as Group B in the first 3 months and then received a telephone-based maintenance program through to 12 months to assess whether such a program would result in an improved level of sustained change. Telephone calls were made to participants in Group C at 4, 5, 6, 8 and 10 months from baseline. The intervention developed for this study was based on behavioural theory and consisted of strategies aimed at affecting mediators and addressing specific determinants of behaviours was based on elements derived from Social Cognitive Theory, the Transtheoretical Model, the Theory of Self-Determination and Motivational Interviewing. The intervention consisted of individual face to face counselling sessions delivered by dietitians/exercise physiologists. The initial session was 1 hour and the review sessions were 45 -60 minutes. The counselling aimed to assist participants in making positive changes to physical activity and dietary behaviours. Participants were encouraged to increase both planned and incidental moderate-intensity physical activity to achieve at least 150 minutes per week for general health and 200 minutes or more per week for weight loss. They were encouraged to aim for a diet low in saturated fats and processed food and a reduction in daily energy intake for weight loss. The counselling sessions included discussion of the participant’s and the Intervention Goals, reflection on current diet and physical activity habits, Goal Setting, review of participants, self-efficacy and motivation for change, discussion of barriers to change, information and education to support dietary and physical activity changes along with review and discussion of progress. Databases were developed to collect data on participant attendance and record implementation of telephone consultations.

Sponsors

Professor Jacob George
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of non-aldoholic fatty liver disease (NAFLD) or hepatitis C (and not receiving anti-viral therapy) Males and females aged 18 years and over Elevated ALT U/L) (>30 in males and >19 in females)

Exclusion criteria

Alcohol intake >30g per day in males or >20g per day in females Current injecting drug use or unstable drug habit Liver cancer Severe Depression (HADDS Score) Cushing's Syndrome Chronic Pancreatitis Other liver diseases identified by appropriate tests including Hepatitis B (negative for hepatitis B surface antigen), autoimmune liver disease (antinuclear antibody, antismooth muscle antibody, anti-liver kidney microsomal antibody and antimitochondrial antibody), Wilson's disease (serum copper and ceruloplasmin levels), alpha-1 antitrypsin deficiency (alpha-1 antitrypsin deficiency (alpha-1 antitrypsin levels and alpha-1 antitrypsin genotype) and hemochromatosis (iron studies and genotyping for C268Y and H63D mutations).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026