# Presentation: 209854

## An Office-Based Low Carbohydrate Diet Intervention in Obese TeensRobert Siegel, Whitney Rich, Evelyn Joseph, Joan Linhardt, Jamie Knight, Jane Khoury,  Stephen Daniels

- We gratefully acknowledge that this study is funded by the Dr. Robert C. and Veronica  Atkins Foundation
- And an
- AHRQ Travel Award

## William Banting

**LETTER **
**ON CORPULENCE,**
- OF all the parasites that affect humanity I do not know of, nor can I imagine, any more distressing than that of Obesity,

## A RTC of a Very Low Carbohydrate Diet (LCD) and a Calorie-Restricted Low Fat Diet ...in Healthy Women

- Brehm et al   *J Clin Endo Met* 2003
- 53 obese females BMI 30-35
- Both groups dropped 450 cals
- 3.9kg Low Fat  vs. 8.5kg LCD

## Effects of LCD on weight loss ...in overweight adolescents

- Sondike et al *J Peds* 2003
- 12 to 18 years BMI>95%
- Followed for 12 weeks
- Low Carb 	n=16   CH<20gm then 40gm
- Low Fat  		n= 14  LF<40gm
- Low Carb 	-9.9_+_ 9.3 kg
- Low Fat  		-4.1_+_ 4.9 kg
- 				P<0.05

## Translating Research into Practice

- In theory, there is no difference between theory and practice, but  in practice there often is.
*Lawrence Berra*
- Cincinnati Pediatric Research Group
- 45 practitioners in 25 practices

**Notes:**
We now turn to  a great american thinker.

Lawrence Yogi Berra who said>>>>>>
What Yogi is talking about here is the chism that we need to bridge

Researchers can outline was efficatious, but there are often barriers to translating research into effective strategies.

Thus Yogi was not only a great philosopher and catcher, but also the father of evidenced based medicine.

## Research Question

- Given
- Greater than 20% of teens have BMI over 95%
- Limited access to community resources and effective interventions
- Success in RCT in medical center setting
- Is a Low Carbohydrate Diet a Practical Intervention in the Office Setting?

## Design/Outcomes

- Prospective Clinical Experience
- Primary Outcomes
- Weight
- BMI
- Secondary Outcomes
- Carbohydrate intake
- Caloric Intake
- Self-Esteem (Rosenberg)

## Population/Setting

- Healthy children 12 to 18 years BMI > 95%
- No chronic medications or conditions associated with weight gain
- No Diabetes
- Normal screening labs: CBC, Renal, glucose, insulin, Thyroid, u/a, lipid profile
- Not pregnant
- 11 practices of the CPRG (14 practitioners)

## Intervention

- Initial Practitioner/Dietician Visit
- Low carbohydrate Diet
- Carbs less than 50 grams/day
- Dietary counseling for adequate intake of vitamins and minerals
- Study visits in the Pediatric Office
- Dietician 0,2wk,1m,2m,4m,6m
- Practitioner 0,2m,4m,6m

## Methods

- Dietician Visits
- Height, Weight, BMI, Diet log
- Practitioner Visits
- Ketones (compliance)
- Blood pressure
- Interval History
- Rosenberg Self Esteem Scale
- 0,2,6 months
- Lipid profile, CBC, Renal at 6 months

## Analysis

- A mixed model approach was used for statistical analysis to allow for the repeated nature of the data and include all subjects with at least two visits

## Results

- 71 recruited-63 had normal screening labs and had at least 2 visits
- N=63
- Mean age 	14.8_+_1.8 (range 12 to 18 yrs)
- Female 		79.4%
- White 		73.5%
- Black		22.1%
- Completed	60.3%

## Results

| Visit | 0 | 2 mos | 4 mos | 6 mos |
| --- | --- | --- | --- | --- |
| Cals | 2401 | 1108 | 1187 | 1153* |
| Carb gm | 324 | 46 | 64 | 62* |
| Fat gm | 87 | 69 | 76 | 68 |
| Protein gm | 84 | 71 | 72 | 73 |

- *P < 0.001

## Results

| Visit | 0 | 2 mos | 4 mos | 6 mos |
| --- | --- | --- | --- | --- |
| Height
Cm | 163.6 | 164.1 | 164.6 | 164.8* |
| Weight
Kg | 93.4 | 89.6 | 88.5 | 88.3* |
| BMI
 | 34.9 | 33.2 | 32.7 | 32.5* |
| BMI %
 | 98.4 | 97.6 | 97.1 | 97.1* |
| Self
Esteem | 16.6 | 15.9 |  | 15.0* |

- *p < 0.05

## Results

- 32 of 38 lost weight
- Most weight gained 5.5 kg
- Most weight lost 23.9 Kg
- Average weight loss was 5.1 Kg

## Compliance

| Visit | 2 week | 2 month | 4 month | 6 month |
| --- | --- | --- | --- | --- |
| Attended | 57 (91%) | 53
(84%) | 40
(63%) | 38
(60%) |
| Carbs<60 | 26
(63%) | 28
(74%) | 23
(63%) | 14
(48%) |

## Results-Lab Studies

| Lab Study | Baseline (SEM) | Month 6 (SEM) |
| --- | --- | --- |
| WBC | 7.1 (0.32) | 7.1 (0.54) |
| HgB | 13.6 (0.13) | 14.0 (0.18)* |
| Hematocrit | 40.1 (0.42) | 41.4 (0.58)* |
| Platlets | 308 (9.3) | 292 (11.6) |
| HDL | 42.3 (1.6) | 44.3 (2.6) |
| LDL | 96.8 (3.0) | 93.4 (3.7) |
| Triglycerides | 99.0 (6.5) | 85.4 (9.4) |
| Total Cholesterol | 160 (3.5) | 152 (4.4) |
| *p<0.05 |  |  |

## Results-Teen Satisfaction

- 46% reported dieting in the past
- 54% felt the diet was  easier to follow
- 68% thought the results were much better with LCD than other diets
- 38% planned on remaining on the LCD beyond one year

## Limitations -6 month Study

- Group
- Size
- No control
- Not random
- Relative Short Term
- Access to dietician (? Available in all settings)
- Completion rate less than 100%

## Conclusions

- A Low Carbohydrate Diet seems to be an effective intervention in overweight teens in the Office setting
- Fat intake did not significantly increase by self report

## What happens beyond 6 months?

- 11 completed one year (17%)
- 3 lost weight
- Weight 	96.9 Kg  initial		96.8 Kg  final
- BMI 	35.7 initial			34.8 final
- Weight range
- 	+32 lbs to -66.4 lbs

## Challenges & Lessons Learned

- IRB restructuring
- Teens transient
- Poor long-term compliance
- Burnout
- Cost of diet

## Future Directions

- Follow this cohort for Three Years
- Get one year follow-up data
- Re-sample Satisfaction