# Abstract

 We examined the effects of a 10--14-weeks inpatient lifestyle modification program, including minimum 90 min of physical activity (PA) five days/week, on body composition, CVD risk factors, and eating behavior in 139 obese subjects (BMI 42.6 ± 5.2 kg/m ^2^ ). Completion rate was 71% ( *n* = 71) in the intensive lifestyle intervention (ILI) group and 85% ( *n* = 33) among waiting list controls. Compared to controls body weight (−17.0 (95% CI: −18.7, −15.3) kg, *P* < 0.0001), fat mass (−15.2 (95% CI: −17.4, −13.1) kg, *P* < 0.0001), fat free mass (−1.2 (95% CI: −2.2, −0.2) kg, *P* = 0.016) and visceral fat (−86.6(95% CI: −97.4, −75.7) cm ^2^ , *P* < 0.0001) were reduced in the ILI-group after 10--14 weeks. Within the ILI-group weight loss was −23.8 (95% CI: −25.9, −21.7) kg, *P* < 0.0001 and -20.3 (95% CI: −23.3, −17.3) kg, *P* < 0.0001, after six and 12 months, respectively. Systolic BP, glucose, triglycerides, and LDL-C were reduced, and HDL-C was increased (all *P* ≤ 0.006) after 10--14 weeks within the ILI group. The reduction in glucose and increase in HDL-C were sustained after 12 months (all *P* < 0.0001). After one year, weight loss was related to increased cognitive restraint and decreased uncontrolled eating (all *P* < 0.05). Thus, ILI including high volume of PA resulted in weight loss with almost maintenance of fat-free mass, favorable changes in CVD risk factors, and eating behavior in subjects with severe obesity. # 3. Results 

## 3.1. Baseline Characteristics Baseline characteristics of the participants who completed the study are shown in [Table 1](#) . The ILI-group was older than the control group, but no other significant differences between the two study groups were seen at baseline. 

## 3.2. Between-Group Changes in Body Composition Compared to the control group, reductions in all BC variables were seen in the ILI-group from baseline to weeks 10--14 ( [Table 2](#) and [Figure 3](#) ). 

## 3.3. Changes in Weight and Body Composition within the ILI-Group Changes in BC within the ILI-group at weeks 10--14, six, and 12 months are shown in [Table 3](#) . After six- and 12-month followup BW reduction was −23.8 ((95% CI: −25.9, −21.7) kg, *P* < 0.0001) and −20.3 ((95% CI: −23.3, −17.3) kg, *P* < 0.0001), respectively, compared with baseline. Within the ILI-group, the mean (SD) percentage weight loss at 12 months was 15.6% (9.2%), and VFA and FM were reduced by 30.8% (21.1%) and 28.8% (17.4%) compared to baseline, respectively, ( [Figure 3](#) ). The proportions of subjects in the ILI-group achieving ≥5%, 10%, 15%, and 20% reduction of their initial weight, respectively, are shown in [Table 4](#) . [Figure 4](#)shows the development in BMI of each subject in the ILI-group. Fifty-two (73.2%) of the subjects had BMI ≥ 40.0 kg/m ^2^ at week 0, and 51 (71.8%) had BMI < 40.0 kg/m ^2^ at 12-month followup. 

## 3.4. Changes in Cardiovascular Disease Risk Factors, Metabolic Syndrome, and Exercise Capacity within the ILI-Group At baseline a total of 27 (38.0%), eight (11.3%), and six (8.5%) in the ILI-group were using blood pressure-, lipid- and glucose-lowering medication, respectively. Changes in CVD risk factors and exercise capacity within the ILI-group are shown in Tables [5](#) and [6](#) . The prevalence of metabolic syndrome was reduced significantly ( *P* < 0.0001) within the ILI-group across the four time points ( [Figure 5](#) ). 

## 3.5. Eating Behavior before and after Intervention Group comparisons of scores on the TFEQ-R21 showed no differences in eating behavior at baseline ( [Table 7](#) ). Eating behavior in the ILI-group and controls prior to and after treatment is shown in [Figure 6](#) . Together these changes resulted in a significant reduction in UE and EE ( *P* = 0.033 and *P* < 0.0001) and increase in CR ( *P* < 0.0001) scores from week 0 to 12 months of followup within the ILI-group, where the main changes occurred during the intervention period and remained quite stable thereafter. [Table 8](#)shows the univariate GLM analysis with respect to changes in weight and eating behaviour, respectively. ::::table-wrap

::: caption
Characteristics of participants and body composition at baseline in the
intensive lifestyle intervention (ILI) group and control group. Data are
given as mean values (standard deviation) or number of subjects and
percentages.
:::

```
                                 ILI ( *n* = 71)   Control ( *n* = 33)   *P*value                
```

______________________________________________________________________

```
                                 *N*               %                    *N*         %          
```

Female/male 42/29 59.2/40.8 21/12 63.6/36.4 0.663 ^a^
Age (year) 45.2 (9.5) 38.5 (9.8) 0.001 ^b^\
Height (cm) 173.2 (8.6) 172.3 (10.4) 0.626 ^b^\
Body mass index (kg/m ^2^ ) 42.8 (4.6) 42.8 (6.3) 0.983 ^b^\
Body weight (kg) 128.9 (19.4) 127.1 (21.6) 0.680 ^b^\
Fat mass (kg) 60.5 (11.0) 60.4 (13.5) 0.986 ^b^\
Fat-free mass (kg) 68.3 (13.2) 67.1 (12.8) 0.676 ^b^\
Skeletal muscle mass (kg) 38.4 (7.9) 37.9 (7.4) 0.760 ^b^\
Visceral fat area (cm ^2^ ) 255.7 (64.7) 245.6 (66.3) 0.464 ^b^\
Highest education\
Primary and/or secondary school 8 ^c^ 12.9 7 21.2 0.178 ^a^
High school 32 ^c^ 51.6 20 60.6\
Higher education 22 ^c^ 35.5 6 18.2\
Employment (full-time job) 34 ^d^ 52.3 16 ^e^ 50.0 0.831 ^a^
Current smoker (yes) 15 ^f^ 23.4 6 18.2 0.552 ^a^

^a^Chi-square; ^b^ independent-samples *t* test; ^c^*n* = 62, ^d^*n* =
65, ^e^*n* = 32, ^f^*n* = 64.:::: ::::table-wrap
::: caption
Between-group differences in changes in body composition from week 0 to
weeks 10--14. Data are mean values (standard deviation or 95% CI).
:::

______________________________________________________________________

```
                            ILI           Control      Between-group differences, mean (95% CI)   *P*value ^a^
                            ( *n* = 71)    ( *n* = 33)                                              
```

______________________________________________________________________

Body mass index (kg/m ^2^ ) −5.8 (1.8) −0.2 (1.0) −5.6 (−6.2, −5.1) \<0.0001

Body weight (kg) −17.5 (6.1) −0.5 (2.8) −17.0 (−18.7, −15.3) \<0.0001

Fat mass (kg) −15.7 (5.3) −0.4 (5.0) −15.2 (−17.4, −13.1) \<0.0001

Fat-free mass (kg) −1.7 (2.5) −0.5 (2.1) −1.2 (−2.2, −0.2) 0.016

Skeletal muscle mass (kg) −1.2 (1.5) 0.2 (3.6) −1.4 (−2.4, −0.4) 0.005



## Visceral fat area (cm ^2^ ) −82.3 (31.6) 4.3 (22.7) −86.6 (−97.4, −75.7) \<0.0001

^a^Independent samples *t* -test.:::: ::::table-wrap
::: caption
Change in body composition from week 0 to 12 months within the ILI group
( *n* = 71).
:::

```
                            Mean change (95% CI) Week 0 to 12 months   *P*value ^a^   Mean change (95% CI) Week 0 to weeks 10--14   *P*value ^a^   Mean change (95% CI) Weeks 10--14 to six months   *P*value ^a^   Mean change (95% CI) Six to 12 months   *P*value ^a^
```

______________________________________________________________________

Body mass index (kg/m ^2^ ) −6.7 (−7.6, −5.7) \<0.0001 −5.8 (−6.2, −5.4) \<0.0001 −2.1 (−2.5, −1.7) \<0.0001 1.2 (0.7, 1.7) \<0.0001
Body weight (kg) −20.3 (−23.3, −17.3) \<0.0001 −17.5 (−18.9, −16.1) \<0.0001 −6.3 (−7.5, −5.1) \<0.0001 3.5 (2.0, 5.1) \<0.0001
Fat mass (kg) −17.5 (−20.1, −14.9) \<0.0001 −15.7 (−17.0, −14.4) \<0.0001 −5.2 (−6.2, −4.1) \<0.0001 3.4 (2.1, 4.7) \<0.0001
Fat-free mass (kg) −2.8 (−3.6, −2.0) \<0.0001 −1.7 (−2.3, −1.2) \<0.0001 −1.1 (−1.5, −0.7) \<0.0001 0.1 (−0.3, 0.6) 0.585
Skeletal muscle mass (kg) −1.7 (−2.2, −1.3) \<0.0001 −1.2 (−1.6, −0.9) \<0.0001 −0.7 (−0.9, −0.5) \<0.0001 0.2 (−0.1, 0.5) 0.225
Visceral fat area (cm ^2^ ) −81.0 (−95.3, −66.7) \<0.0001 −82.3 (−89.8, −74.8) \<0.0001 −22.0 (−28.1, −15.9) \<0.0001 23.3 (15.5, 31.1) \<0.0001

^a^Paired samples *t* -test.:::: ::::table-wrap
::: caption
Subjects in the ILI-group achieving ≥5%, 10%, 15%, and 20% weight loss
from initial weight at weeks 10--14, six, and 12 months. Data are number
of subjects (percentage).
:::

```
                 Weeks 10--14   Six months    12 months
```

______________________________________________________________________

≥5% weight loss 71 (100.0%) 71 (100.0%) 65 (91.5%)
≥10% weight loss 57 (80.3%) 67 (94.4%) 48 (67.6%)
≥15% weight loss 20 (28.2%) 21 (29.6%) 35 (49.3%)
≥20% weight loss 4 (5.6%) 27 (38.0%) 19 (26.8%):::: ::::table-wrap
::: caption
Change in values for cardiovascular disease risk factors within the
ILI-group. Data are mean values (SD or 95% CI).
:::

______________________________________________________________________

```
                                       Mean          Mean change           *P*value       Mean change             *P*value       Mean change                 *P*value       Mean change       *P*value
                                       Week 0         Week 0 to 12 months                   Week 0 to weeks 10--14                  Weeks 10--14 to six months                  Six to 12 months   
```

______________________________________________________________________

s-BP (mmHg)

All ( *n* = 57) 132.3 (10.7) −2.8 (−6.0, 0.4) 0.082 ^a^ −6.4 (−9.1, −3.7) \<0.0001 ^a^ 1.1 (−1.7, 4.0) 0.431 ^a^ 2.5 (−0.5, 5.4) 0.097 ^a^

No blood pressure lowering ( *n* = 37) 130.4 (8.8) −3.8 (−6.9, −0.7) 0.018 ^b^ −5.4 (−8.4, −2.4) 0.001 ^b^ 0.3 (−3.2, 3.8) 0.877 ^b^ 1.4 (−1.7, 4.4) 0.368 ^b^

d-BT (mmHg)

All ( *n* = 57) 83.7 (6.1) −1.8 (−4.0, 0.3) 0.094 ^a^ −1.3 (−3.2, 0.6) 0.175 ^a^ −2.0 (−4.3, 0.3) 0.088 ^a^ 1.5 (−0.7, 3.7) 0.173 ^a^

No blood pressure lowering ( *n* = 37) 83.2 (5.4) −3.5 (−6.3, −0.7) 0.015 ^b^ −2.8 (−5.0, −0.7) 0.012 ^b^ −2.3 (−5.2, 0.6) 0.112 ^b^ 1.6 (−1.2, 4.4) 0.245 ^b^

GLUC (mmol/L)

All ( *n* = 58) 5.8 (1.3) −0.5 (−0.7, −0.3) \<0.0001 ^a^ −0.7 (−0.9, −0.5) \<0.0001 ^a^ 0.1 (−0.1, 0.2) 0.258 ^a^ 0.1 (0.0, 0.3) 0.150 ^a^

No glucose lowering ( *n* = 54) 5.6 (0.8) −0.4 (−0.6, −0.2) \<0.0001 ^b^ −0.6 (−0.8, −0.4) \<0.0001 ^b^ 0.1 (−0.1, 0.2) 0.260 ^b^ 0.1 (−0.1, 0.2) 0.300 ^b^

HDL (mmol/L)

All ( *n* = 60) 1.1 (0.3) 0.3 (0.3, 0.4) \<0.0001 ^a^ 0.1 (0.0, 0.1) 0.001 ^a^ 0.2 (0.1, 0.2) \<0.0001 ^a^ 0.1 (0.0, 0.2) 0.001 ^a^

No lipid lowering ( *n* = 52) 1.1 (0.3) 0.3 (0.3, 0.4) \<0.0001 ^b^ 0.1 (0.0, 0.1) 0.002 ^b^ 0.2 (0.1, 0.2) \<0.0001 ^b^ 0.1 (0.0, 0.2) 0.004 ^b^

LDL (mmol/L)

All ( *n* = 59) 2.9 (0.9) 0.4 (0.2, 0.6) \<0.0001 ^a^ −0.2 (−0.3, −0.1) 0.005 ^a^ 0.3 (0.2, 0.4) \<0.0001 ^a^ 0.3 (0.2, 0.4) \<0.0001 ^a^

No lipid lowering ( *n* = 51) 3.1 (0.8) 0.3 (0.1, 0.5) 0.002 ^b^ −0.3 (−0.4, −0.1) \<0.0001 ^b^ 0.2 (0.1, 0.3) \<0.0001 ^b^ 0.3 (0.2, 0.5) \<0.0001 ^b^

TG (mmol/L)

All ( *n* = 59) 1.4 (0.6) −0.1 (−0.2, 0.1) 0.231 ^a^ −0.2 (−0.3, −0.2) \<0.0001 ^a^ 0.0 (0.0, 0.2) 0.066 ^a^ 0.1 (−0.1, 0.2) 0.420 ^a^

No lipid lowering ( *n* = 51) 1.4 (0.6) −0.1 (−0.3, 0.1) 0.185 ^b^ −0.2 (−0.3, −0.2) \<0.0001 ^b^ 0.0 (−0.1, 0.1) 0.451 ^b^ 0.1 (0.0, 0.3) 0.126 ^b^

Tot C (mmol/L)

All ( *n* = 60) 4.7 (1.1) 0.5 (0.3, 0.7) \<0.0001 ^a^ −0.1 (−0.3, 0.0) 0.155 ^a^ 0.4 (0.2, 0.5) \<0.0001 ^a^ 0.3 (0.1, 0.4) 0.002 ^a^

No lipid lowering ( *n* = 52) 4.9 (1.0) 0.4 (0.2, 0.6) \<0.0001 ^b^ −0.2 (−0.3, 0.0) 0.015 ^b^ 0.3 (0.2, 0.5) \<0.0001 ^b^ 0.3 (0.1, 0.5) 0.002 ^b^

Waist circumferences (cm)



## All ( *n* = 70) 123.5 (12.8) −14.9 (−16.9, −13.0) \<0.0001 ^a^ −14.0 (−14.9, −13.0) \<0.0001 ^a^ −4.6 (−5.6, −3.5) \<0.0001 ^a^ 3.6 (2.5, 4.7) \<0.0001 ^a^

s-BP: blood pressure systolic, d-BP: blood pressure diastolic, GLUC:
fasting glucose, HDL: high-density lipoprotein cholesterol, LDL:
low-density lipoprotein cholesterol, TG: triglycerides, Tot C: total
cholesterol. ^a^ GLM adjusted for age, gender, and relevant medication
at baseline (HDL, LDL, Tot C, and TG adjusted for lipid-lowering
medication at baseline; s-BP and d-BP adjusted for blood
pressure-lowering medication at baseline; and GLUC adjusted for
glucose-lowering medication at baseline), ^b^ subgroup analysis of
participants not using relevant medication at baseline, GLM adjusted for
age and gender.:::: ::::table-wrap
::: caption
Change in exercise capacity within the ILI-group. Data are mean values
(SD or 95% CI).
:::

______________________________________________________________________

```
                                                           Mean       Mean change          *P*value       Mean change             *P*value       Mean change                 *P*value       Mean change        *P*value
                                                           Week 0      Week 0 to 12 months                  Week 0 to weeks 10--14                  Weeks 10--14 to six months                  Six to 12 months    
```

______________________________________________________________________

10-metre shuttle run test, exercise time (min) ( *n* = 43) 9.3 (2.9) 4.2 (3.3, 5.2) \<0.0001 ^a^ 4.7 (3.9, 5.6) \<0.0001 ^a^ 0.7 (0.3, 1.1) 0.002 ^a^ −1.2 (−1.6, −0.7) \<0.0001 ^a^



## 750-metre walk test, exercise time (min) ( *n* = 47) 6.9 (1.0) −1.4 (−1.6, −1.1) \<0.0001 ^a^ −1.2 (−1.4, −1.0) \<0.0001 ^a^ −0.4 (−0.5, −03) \<0.0001 ^a^ 0.2 (0, 0.4) 00.015 ^a^

^a^Paired samples *t* -test.:::: ::::table-wrap
::: caption
Self-assessment of eating behavior (TFEQ-R21) at baseline in the
intensive lifestyle intervention (ILI) group and control group. Data are
given as mean values (standard deviation).
:::

```
        ILI               Control           *P*value ^a^
```

______________________________________________________________________

TFEQ CR 42.0 (11.4) ^b^ 43.2 (12.4) ^d^ 0.635
TFEQ UE 44.6 (13.6) ^c^ 48.8 (12.0) ^d^ 0.150
TFEQ EE 53.0 (23.5) ^c^ 52.4 (26.2) ^d^ 0.907

^a^Independent samples *t* -test, ^b^*n* = 56, ^c^*n* = 55, ^d^*n* = 33.

UE: Uncontrolled eating, CR: cognitive restraint, EE: emotional eating.:::: ::::table-wrap
::: caption
Univariate GLM between changes in eating behavior and weight change.
:::

Parameter/independent variable B 95% CI *P*value

______________________________________________________________________

Regression 1 ( *n* = 60): dependent variable weight change week 0 to 12 months

Change CR week 0 to 12 months −0.310 −0.501, −0.120 0.002
Change UE week 0 to 12 months 0.252 0.008, 0.496 0.043
Change EE week 0 to 12 months 0.016 −0.135, 0.167 0.831

Regression 2 ( *n* = 62): dependent variable weight change week 0 to weeks 10--14

Change CR week 0 to 10--14 −0.152 −0.230, −0.074 0.000
Change UE week 0 to 10--14 0.064 −0.049, 0.177 0.262
Change EE week 0 to 10--14 0.008 −0.089, 0.073 0.843

Regression 3 ( *n* = 62): dependent variable weight change weeks 10--14 to 6 months

Change CR weeks 10--14 to 6 months 0.005 −0.079, 0.090 0.898
Change UE weeks 10--14 to 6 months 0.011 −0.112, 0.135 0.856
Change EE weeks 10--14 to 6 months 0.087 0.007, 0.168 0.033

Regression 4 ( *n* = 61): dependent variable weight change 6 to 12 months

Change CR week 6 months to 12 months −0.108 −0.274, 0.057 0.196
Change UE week 6 months to 12 months −0.019 −0.212, 0.173 0.842
Change EE week 6 months to 12 months 0.030 −0.100, 0.160 0.647::::


Extracted trial result:
Outcome: baseline fat mass (continuous)
Intervention: Intensive lifestyle intervention (ILI) group
Comparator: Waiting list control
Intervention group size: 71
Intervention mean: 60.5
Intervention standard deviation: 11
Comparator group size: 33
Comparator mean: 60.4
Comparator standard deviation: 13.5