Cardiovascular DiseasesPhase 3NCT00000459
Dietary Intervention Study in Children (DISC)
A Phase 3 study testing diet, fat-restricted in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the feasibility, acceptability, efficacy, and safety of dietary intervention in free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
- What is being tested?
- diet, fat-restricted
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1986to Jan 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Children, ages 8 to 10, with elevated LDL-C levels.
About this study
To assess the feasibility, acceptability, efficacy, and safety of dietary intervention in free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels.
Read the detailed description
BACKGROUND:
Several lines of evidence provided the rationale for intervening in children. A large body of autopsy and pathologic evidence had accumulated showing that atherosclerosis, including fatty streaks, increased surface involvement, and advanced microscopic lesions, began in childhood. Blood cholesterol levels tracked from childhood to adulthood, with tracking correlations ranging from .6 to .8. Therefore, a high proportion of children with high levels of cholesterol have high levels as adults. Family clustering of risk factors had also been reported. Studies showed 2-3 times increased prevalence of coronary heart disease in adult relatives of children with high cholesterol compared to children with normal cholesterol, and 2.2 times increased prevalence in high cholesterol in children who had a parent or grandparent with premature coronary heart disease compared with children who did not have a family history of premature heart disease. Finally, there was high likelihood that environmental influences on coronary heart disease risk factors had their behavioral antecents in childhood. Thus, dietary habits which contributed toward elevated blood cholesterol levels were likely to have developed early in life, and it was hoped that behavioral change achieved during childhood was likely to persist into adulthood.
Although numerous studies had shown that dietary modification could lower blood cholesterol levels in adults, only a few studies had shown this effect in children, and none were long-term. Furthermore, the impact on long-term growth and development in children had not been studied. Concerns were raised about the safety of cholesterol-lowering diets in children, particularly during peak growing years. These concerns included possible deficits in growth and nutrient adequacy, and potential adverse psychological effects. This paucity of data was a potential barrier to active prevention measures. To fill this gap in knowledge, the DISC trial, a randomized, controlled clinical trial, tested the efficacy and safety of long-term dietary intervention for reduction of serum LDL-C levels in children during puberty.
DESIGN NARRATIVE:
In the feasibility study, children of both sexes, ages 8 to 10 at baseline starting in 1987, were randomized to either a control group or to a usual care group for whom more intensive dietary intervention for the child and the family was directed. The feasibility study lasted 16 months. The full-scale trial began in December 1988 with the randomization of a total of 663 children. At baseline, mean LDL-C levels, nutrient intakes, anthropometric measurements, nutritional biochemical levels, and psychosocial measures were similar in the two groups. The intervention group was assigned to a series of group and individual sessions to teach the children and their families to follow a diet containing 28 percent of calories as total fat, dietary cholesterol intake less than 75 mg/1000 kcal, and up to 9% of calories from polyunsaturated fat. The diets were designed to meet nutritional requirements of growing children. The usual care group was provided a packet of general dietary information only. The primary efficacy outcome was a difference in changes in LDL-C levels between the two groups at 36 months. Primary safety endpoints were change in height and serum ferritin levels. Secondary safety outcomes included serum zinc, retinol, albumin levels, red blood cell folate, ratio of LDL-C to high-density lipoprotein cholesterol, sexual maturation, cognitive development, and psychosocial assessments. Recruitment was completed in July 1990. Intervention and follow-up was extended until 1997 when the participants were on average 17 years old. Data analysis continued through January 1999.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Being tested
- diet, fat-restricted
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet, fat-restrictedBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startDec 1986
- Study completionJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Bruce Barton, Maryland Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000459
- Sponsor's protocol ID
- 48
- Other IDs
- U01HL037947, U01HL037948, U01HL037954, U01HL037962, U01HL037966, U01HL037975, U01HL038110
- Status last verified
- Mar 2005
- First submitted
- 27 Oct 1999
- Last updated
- 5 May 2016
- Results posted
- No
Publications
Van Horn LV, Gernhofer N, Moag-Stahlberg A, Farris R, Hartmuller G, Lasser VI, Stumbo P, Craddick S, Ballew C. Dietary assessment in children using electronic methods: telephones and tape recorders. J Am Diet Assoc. 1990 Mar;90(3):412-6.
PubMed 2307817Dietary intervention study in children (DISC) with elevated low-density-lipoprotein cholesterol. Design and baseline characteristics. DISC Collaborative Research Group. Ann Epidemiol. 1993 Jul;3(4):393-402. doi: 10.1016/1047-2797(93)90067-e.
PubMed 8275216van Horn LV, Stumbo P, Moag-Stahlberg A, Obarzanek E, Hartmuller VW, Farris RP, Kimm SY, Frederick M, Snetselaar L, Liu K. The Dietary Intervention Study in Children (DISC): dietary assessment methods for 8- to 10-year-olds. J Am Diet Assoc. 1993 Dec;93(12):1396-403. doi: 10.1016/0002-8223(93)92241-o.
PubMed 8245373Hartmuller VW, Snetselaar L, Van Horn L, et al: Creative Approaches to Cholesterol-Lowering Used in the Dietary Intervention Study in Children (DISC). Top Clin Nutr, 10:71-78, 1994.
Efficacy and safety of lowering dietary intake of fat and cholesterol in children with elevated low-density lipoprotein cholesterol. The Dietary Intervention Study in Children (DISC). The Writing Group for the DISC Collaborative Research Group. JAMA. 1995 May 10;273(18):1429-35. doi: 10.1001/jama.1995.03520420045036.
PubMed 7723156Stevens VJ, Obarzanek E, Franklin FA, et al for the DISC Collaborative Research Group. Dietary Intervention Study in Children (DISC): intervention design and participation. J Nutr Educ 1995;27:133-140.
Luepker RV. Reducing blood cholesterol levels in children. What have we learned from the DISC study? JAMA. 1995 May 10;273(18):1461-2. No abstract available.
PubMed 7723162Simons-Morton DG, Hunsberger SA, Van Horn L, Barton BA, Robson AM, McMahon RP, Muhonen LE, Kwiterovich PO, Lasser NL, Kimm SY, Greenlick MR. Nutrient intake and blood pressure in the Dietary Intervention Study in Children. Hypertension. 1997 Apr;29(4):930-6. doi: 10.1161/01.hyp.29.4.930.
PubMed 9095079Obarzanek E, Hunsberger SA, Van Horn L, Hartmuller VV, Barton BA, Stevens VJ, Kwiterovich PO, Franklin FA, Kimm SY, Lasser NL, Simons-Morton DG, Lauer RM. Safety of a fat-reduced diet: the Dietary Intervention Study in Children (DISC). Pediatrics. 1997 Jul;100(1):51-9. doi: 10.1542/peds.100.1.51.
PubMed 9200359Kwiterovich PO Jr, Barton BA, McMahon RP, Obarzanek E, Hunsberger S, Simons-Morton D, Kimm SY, Friedman LA, Lasser N, Robson A, Lauer R, Stevens V, Van Horn L, Gidding S, Snetselaar L, Hartmuller VW, Greenlick M, Franklin F Jr. Effects of diet and sexual maturation on low-density lipoprotein cholesterol during puberty: the Dietary Intervention Study in Children (DISC). Circulation. 1997 Oct 21;96(8):2526-33. doi: 10.1161/01.cir.96.8.2526.
PubMed 9355889Reimers TM, Brown KM, Van Horn L, Stevens V, Obarzanek E, Hartmuller VW, Snetselaar L, von Almen TK, Chiostri J. Maternal acceptability of a dietary intervention designed to lower children's intake of saturated fat and cholesterol: the Dietary Intervention Study in Children (DISC). J Am Diet Assoc. 1998 Jan;98(1):31-4. doi: 10.1016/s0002-8223(98)00010-8.
PubMed 9434647Berg-Smith SM, Stevens VJ, Brown KM, Van Horn L, Gernhofer N, Peters E, Greenberg R, Snetselaar L, Ahrens L, Smith K. A brief motivational intervention to improve dietary adherence in adolescents. The Dietary Intervention Study in Children (DISC) Research Group. Health Educ Res. 1999 Jun;14(3):399-410. doi: 10.1093/her/14.3.399.
PubMed 10539230Obarzanek E, Kimm SY, Barton BA, Van Horn L L, Kwiterovich PO Jr, Simons-Morton DG, Hunsberger SA, Lasser NL, Robson AM, Franklin FA Jr, Lauer RM, Stevens VJ, Friedman LA, Dorgan JF, Greenlick MR; DISC Collaborative Research Group. Long-term safety and efficacy of a cholesterol-lowering diet in children with elevated low-density lipoprotein cholesterol: seven-year results of the Dietary Intervention Study in Children (DISC). Pediatrics. 2001 Feb;107(2):256-64. doi: 10.1542/peds.107.2.256.
PubMed 11158455Lauer RM, Obarzanek E, Hunsberger SA, Van Horn L, Hartmuller VW, Barton BA, Stevens VJ, Kwiterovich PO Jr, Franklin FA Jr, Kimm SY, Lasser NL, Simons-Morton DG. Efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol in children with elevated LDL cholesterol: the Dietary Intervention Study in Children. Am J Clin Nutr. 2000 Nov;72(5 Suppl):1332S-1342S. doi: 10.1093/ajcn/72.5.1332s.
PubMed 11063475Lavigne JV, Brown KM, Gidding S, Evans M, Stevens VJ, von Almen TK, Ewart C, Weil C. A cholesterol-lowering diet does not produce adverse psychological effects in children: three-year results from the dietary intervention study in children. Health Psychol. 1999 Nov;18(6):604-13. doi: 10.1037//0278-6133.18.6.604.
PubMed 10619534
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Study in Children (DISC)
- ClinicalTrials.gov ID
- NCT00000459
- Acronym / sponsor ID
- 48
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1986
- Study completion
- Jan 1999 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the feasibility, acceptability, efficacy, and safety of dietary intervention in free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels.
Detailed description
BACKGROUND:
Several lines of evidence provided the rationale for intervening in children. A large body of autopsy and pathologic evidence had accumulated showing that atherosclerosis, including fatty streaks, increased surface involvement, and advanced microscopic lesions, began in childhood. Blood cholesterol levels tracked from childhood to adulthood, with tracking correlations ranging from .6 to .8. Therefore, a high proportion of children with high levels of cholesterol have high levels as adults. Family clustering of risk factors had also been reported. Studies showed 2-3 times increased prevalence of coronary heart disease in adult relatives of children with high cholesterol compared to children with normal cholesterol, and 2.2 times increased prevalence in high cholesterol in children who had a parent or grandparent with premature coronary heart disease compared with children who did not have a family history of premature heart disease. Finally, there was high likelihood that environmental influences on coronary heart disease risk factors had their behavioral antecents in childhood. Thus, dietary habits which contributed toward elevated blood cholesterol levels were likely to have developed early in life, and it was hoped that behavioral change achieved during childhood was likely to persist into adulthood.
Although numerous studies had shown that dietary modification could lower blood cholesterol levels in adults, only a few studies had shown this effect in children, and none were long-term. Furthermore, the impact on long-term growth and development in children had not been studied. Concerns were raised about the safety of cholesterol-lowering diets in children, particularly during peak growing years. These concerns included possible deficits in growth and nutrient adequacy, and potential adverse psychological effects. This paucity of data was a potential barrier to active prevention measures. To fill this gap in knowledge, the DISC trial, a randomized, controlled clinical trial, tested the efficacy and safety of long-term dietary intervention for reduction of serum LDL-C levels in children during puberty.
DESIGN NARRATIVE:
In the feasibility study, children of both sexes, ages 8 to 10 at baseline starting in 1987, were randomized to either a control group or to a usual care group for whom more intensive dietary intervention for the child and the family was directed. The feasibility study lasted 16 months. The full-scale trial began in December 1988 with the randomization of a total of 663 children. At baseline, mean LDL-C levels, nutrient intakes, anthropometric measurements, nutritional biochemical levels, and psychosocial measures were similar in the two groups. The intervention group was assigned to a series of group and individual sessions to teach the children and their families to follow a diet containing 28 percent of calories as total fat, dietary cholesterol intake less than 75 mg/1000 kcal, and up to 9% of calories from polyunsaturated fat. The diets were designed to meet nutritional requirements of growing children. The usual care group was provided a packet of general dietary information only. The primary efficacy outcome was a difference in changes in LDL-C levels between the two groups at 36 months. Primary safety endpoints were change in height and serum ferritin levels. Secondary safety outcomes included serum zinc, retinol, albumin levels, red blood cell folate, ratio of LDL-C to high-density lipoprotein cholesterol, sexual maturation, cognitive development, and psychosocial assessments. Recruitment was completed in July 1990. Intervention and follow-up was extended until 1997 when the participants were on average 17 years old. Data analysis continued through January 1999.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet, fat-restricted | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Background: PubMed 2307817Van Horn LV, Gernhofer N, Moag-Stahlberg A, Farris R, Hartmuller G, Lasser VI, Stumbo P, Craddick S, Ballew C. Dietary assessment in children using electronic methods: telephones and tape recorders. J Am Diet Assoc. 1990 Mar;90(3):412-6.
- Background: PubMed 8275216Dietary intervention study in children (DISC) with elevated low-density-lipoprotein cholesterol. Design and baseline characteristics. DISC Collaborative Research Group. Ann Epidemiol. 1993 Jul;3(4):393-402. doi: 10.1016/1047-2797(93)90067-e.
- Background: PubMed 8245373van Horn LV, Stumbo P, Moag-Stahlberg A, Obarzanek E, Hartmuller VW, Farris RP, Kimm SY, Frederick M, Snetselaar L, Liu K. The Dietary Intervention Study in Children (DISC): dietary assessment methods for 8- to 10-year-olds. J Am Diet Assoc. 1993 Dec;93(12):1396-403. doi: 10.1016/0002-8223(93)92241-o.
- BackgroundHartmuller VW, Snetselaar L, Van Horn L, et al: Creative Approaches to Cholesterol-Lowering Used in the Dietary Intervention Study in Children (DISC). Top Clin Nutr, 10:71-78, 1994.
- Background: PubMed 7723156Efficacy and safety of lowering dietary intake of fat and cholesterol in children with elevated low-density lipoprotein cholesterol. The Dietary Intervention Study in Children (DISC). The Writing Group for the DISC Collaborative Research Group. JAMA. 1995 May 10;273(18):1429-35. doi: 10.1001/jama.1995.03520420045036.
- BackgroundStevens VJ, Obarzanek E, Franklin FA, et al for the DISC Collaborative Research Group. Dietary Intervention Study in Children (DISC): intervention design and participation. J Nutr Educ 1995;27:133-140.
- Background: PubMed 7723162Luepker RV. Reducing blood cholesterol levels in children. What have we learned from the DISC study? JAMA. 1995 May 10;273(18):1461-2. No abstract available.
- Background: PubMed 9095079Simons-Morton DG, Hunsberger SA, Van Horn L, Barton BA, Robson AM, McMahon RP, Muhonen LE, Kwiterovich PO, Lasser NL, Kimm SY, Greenlick MR. Nutrient intake and blood pressure in the Dietary Intervention Study in Children. Hypertension. 1997 Apr;29(4):930-6. doi: 10.1161/01.hyp.29.4.930.
- Background: PubMed 9200359Obarzanek E, Hunsberger SA, Van Horn L, Hartmuller VV, Barton BA, Stevens VJ, Kwiterovich PO, Franklin FA, Kimm SY, Lasser NL, Simons-Morton DG, Lauer RM. Safety of a fat-reduced diet: the Dietary Intervention Study in Children (DISC). Pediatrics. 1997 Jul;100(1):51-9. doi: 10.1542/peds.100.1.51.
- Background: PubMed 9355889Kwiterovich PO Jr, Barton BA, McMahon RP, Obarzanek E, Hunsberger S, Simons-Morton D, Kimm SY, Friedman LA, Lasser N, Robson A, Lauer R, Stevens V, Van Horn L, Gidding S, Snetselaar L, Hartmuller VW, Greenlick M, Franklin F Jr. Effects of diet and sexual maturation on low-density lipoprotein cholesterol during puberty: the Dietary Intervention Study in Children (DISC). Circulation. 1997 Oct 21;96(8):2526-33. doi: 10.1161/01.cir.96.8.2526.
- Background: PubMed 9434647Reimers TM, Brown KM, Van Horn L, Stevens V, Obarzanek E, Hartmuller VW, Snetselaar L, von Almen TK, Chiostri J. Maternal acceptability of a dietary intervention designed to lower children's intake of saturated fat and cholesterol: the Dietary Intervention Study in Children (DISC). J Am Diet Assoc. 1998 Jan;98(1):31-4. doi: 10.1016/s0002-8223(98)00010-8.
- Background: PubMed 10539230Berg-Smith SM, Stevens VJ, Brown KM, Van Horn L, Gernhofer N, Peters E, Greenberg R, Snetselaar L, Ahrens L, Smith K. A brief motivational intervention to improve dietary adherence in adolescents. The Dietary Intervention Study in Children (DISC) Research Group. Health Educ Res. 1999 Jun;14(3):399-410. doi: 10.1093/her/14.3.399.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Barton
Maryland Medical Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diet, fat-restricted in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000459, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.