• Aim: To explore whether intensive treatment produced greater weight loss and weight stability, compared with less-intensive treatment
• To define a reasonable level of input from health care personnel to reach adequate treatment results.

• Patients referred to clinic due to obesity with complications and diagnoses like diabetes mellitus Type 2, hypertension, dyslipoporteinaemia, polycystic ovary disease and sleep apnea
• Meeting with physician for initial medical examination and discussion of treatment offered
• Individual meeting with the dietitian
• Attended an information meeting where they decided if they wanted to participate; signed consent forms
• Signed contract with obligations between clinic and patients outlined.

• Compared two group treatment programs for obese outpatients
• Both programs included behavior modification, nutrition counseling, very-low-calorie diet (VLCD) and continuous measuring of metabolic and anthropometrical status
• Levels of intensity varied.

Treatment Program

1. Four-day food record by household measures
2. VLCD
   • The VLCD periods were 25 days
   • The subjects were instructed to decrease their energy intake successively during three days from 800kcal down to a level of approximately 200kcal per day and to keep this intake during the following 19 days
   • The energy intake was progressively increased again to 800kcal per day during the last three days of the VLCD period
   • The subjects were instructed to drink liquids every two hours
   • The liquid prescribed consisted of water, herbal tea, different kinds of fruit and vegetable juice.
3. Dietary treatment
   • After the VLCD period, ordinary food was gradually introduced
   • All subjects were prescribed an individualized hypocaloric diet aiming at an energy deficit of approximately 600kcals per day
   • Education in nutrition and food habits was given and self-monitoring and strategies to control eating behavior were discussed.
4. Health education: Meetings included the whole family and included information on risk factors of being obese, connections between food, health and disease, metabolism, appetite control and medical risk factors and basic facts about energy and the ABCs of nutrition.
5. Behavior treatment
   • Self-monitoring was used as a tool to follow the behavior change process
   • Participants evaluated progress and identified personal and environmental influences that regulate eating and physical activity
   • The focus was on eating behavior, hunger and craving, relapse situations, physical activities and satisfaction and happiness.

Recruitment

Participants were recruited after they were referred to the clinic, due to obesity.

Design

Two-year randomized clinical trial (RCT).

Intervention

Participants were randomized to one of two treatment groups: More intense (Group One) and less intense (Group Two), according to gender, age and BMI.

• Group One: Continuous intensive treatment with planned group meetings every fortnight during the first year and six meetings during the second year for a total of 43 meetings in two years. More intensive care, including the possibility to repeat the self-monitoring and obtain more information and education in nutrition, food habits and strategies to control the eating behavior.
• Group Two: Met less often, with planned group meetings every third month for a total of 27 meetings in two years. Less contact with supervisors, fewer repetitions with self-monitoring and less possibilities of nutrition counseling.

Statistical Analysis

• Based on treatment effects or high or low attendance (change from baseline) to three, six, 12 and 24 months within and between groups via paired and unpaired T-tests, two-tailed, P<0.05
• Data log transformed if skewed, as defined as W<0.95 in Shapiro-Wilk's test
• 95% confidence intervals also presented for weight reduction and attendance.

Timing of Measurements

Anthropometric and metabolic measures baseline and every third month up to 24 months.

Dependent Variables 

• Variable One: Body weight, as measured in kilograms on a digital scale without shoes and with light clothing, with an accuracy of 0.1kg
• Variable Two: Body mass index, calculated as body weight divided by height (in meters rounded to 0.5cm), squared
• Variable Three: Systolic blood pressure (mmHg) in right arm with a sphygmomanometer, cuff size 15.45cm, recordings to the nearest 2.0mmHg, twice after 10 minutes' supine rest and the mean of the two measurements was used in the analysis
• Variable Four: Diastolic blood pressure (mmHg) in right arm with a sphygmomanometer, cuff size 15.45cm, recordings to the nearest 2.0mmHg, twice after 10 minutes' supine rest and the mean of the two measurements was used in the analysis
• Variable Five: Fasting plasma glucose (mmol per L), by glucose oxidase method
• Variable Six: Fasting plasma insulin (mU per L), by the Phadebas test (Pharmacia, Uppsala, Sweden).

Independent Variables 

• Treatment group (more intense Group One vs. less intense Group Two) 
• Attendance (high vs. low): High defined as two-thirds (over 60%) compliance at all treatment interventions
• Time: Baseline, three, six , 12 and 24 months).

Control Variables

None. 

Initial N

• 43 subjects (39 female, four male)
• Group One: 22 subjects
• Group Two: 21 subjects.

Attrition (Final N)

• 32
• Group One: 17 subjects
• Group Two: 15 subjects) (26%).

Age

• Group One: 40.7 (25 to 60)
• Group Two: 39.4 (26 to 57).

Ethnicity

Swedish.

Other Relevant Demographics

All had previous treatment for obesity; groups similar on all demographic characteristics.

Anthropometrics

Groups similar on all anthropometric characteristics.

Location

Sweden.

IV: Attendance (High vs. Low) and Weight Reduction (kg)

IV: Treatment Group One (more intense) N=17 vs. Group Two (less intense) N=15
IV: Time (baseline, three, six, 12 and 24 months.

 

Data are mean and SEM

^*P<0.05, ^**P<0.01, ^***P<0.001 compared with baseline, differences within groups. No significant differences between groups except from diastolic blood pressure at 24 months, ^*P<0.05).

^aConfidence interval for difference between the two groups regarding changes from baseline.

Other Findings

• After two years, 28 subjects (65%) reached weight stability with an average weight reduction of 8.5 (0.2-37.9) kg
• 12 subjects (28%) lost 10-25%, eight subjects (18.6%) lost 5-10% and eight subjects (18.6%) lost 0-5%, four subjects (9.3%) gained 0-8% and 11 subjects (26%) dropped out. 

• Difficult to create homogeneous groups
• Despite difference in intensity of treatment between the two groups, no significant difference between two groups in weight reduction
• High attendance over time was associated with higher weight reduction
• Subjects appreciated continuous feedback, which may improve results
• Treatment with VLCD and an active follow-up treatment seem to relate to long-term weight-maintenance success, where rapid and major weight reduction was suggested to be an important motivation factor
• No significant difference in dropout rates, but long holidays, such as Christmas and during summer time, were critical times for dropout
• 10-year follow-up period desirable
• Patient's readiness to change health behavior an important factor and should be screened for to target those most likely to be successful.

• Article fairly easy to read and understand
• Statistics presented in easy to understand manner and consistent with what was proposed
• Described in such a way as to be fairly easily replicated and appears to be generalizable to the greater population of obese persons
• VLCD component to stimulate more rapid weight loss initially appeared to have been motivating factor, followed by behavior modification, nutrition counseling and continual communication.