NCT00942097

Brief Summary

The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant women with overweight and class I obesity with suspicion of a mental disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

July 16, 2009

Last Update Submit

May 8, 2013

Conditions

OverweightPregnancyMental Disorder

Keywords

Homeopathyoverweightobesitymental disorderpregnancyOverweight pregnant women with suspicious mental disorder

Outcome Measures

Primary Outcomes (1)

  • Weight

    9 months

Secondary Outcomes (6)

  • Comorbidities

    9 months

  • Newborn weight

    9 months

  • Pregnancy period

    9 months

  • Collateral effects

    9 months

  • Self perception health

    9 months

  • +1 more secondary outcomes

Study Arms (2)

Nutritional plus Placebo (homeopathy)

PLACEBO COMPARATOR

Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.

Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, PhosDrug: Homeopathy and Nutritional oriented diet

Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos

ACTIVE COMPARATOR

Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)

Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, PhosDrug: Homeopathy and Nutritional oriented diet

Interventions

Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, PhosDRUG

CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.

Also known as: Sulphur, Puls, Lyc, Lack-t, Conium-m, Nux-v, Calc-c, Sep, Phosphorus
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc PhosNutritional plus Placebo (homeopathy)
Homeopathy and Nutritional oriented dietDRUG

Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.

Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc PhosNutritional plus Placebo (homeopathy)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women with less than 28 weeks,
  • BMI from 26 to 35 Kg/ m2,
  • SRQ-20 positive.

You may not qualify if:

  • Diabetes
  • Cardiopathies
  • Hypertension
  • Nephropathies
  • Psychiatric treatment
  • Drug users
  • Pulmonary Chronic Disease
  • Suicidal ideas
  • No eating (appetites)
  • Problems of BMI measurements (disabled people)
  • Concomitant homeopathic treatment
  • People who are looking for just 1 medical appointment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amparo Maternal Maternidade Social

São Paulo, São Paulo, 04062-023, Brazil

Location

Related Publications (67)

  • Keppel KG, Taffel SM. Pregnancy-related weight gain and retention: implications of the 1990 Institute of Medicine guidelines. Am J Public Health. 1993 Aug;83(8):1100-3. doi: 10.2105/ajph.83.8.1100.

    PMID: 8342716BACKGROUND

  • Horton R. The neglected epidemic of chronic disease. Lancet. 2005 Oct 29-Nov 4;366(9496):1514. doi: 10.1016/S0140-6736(05)67454-5. No abstract available.

    PMID: 16257331BACKGROUND

  • Strong K, Mathers C, Leeder S, Beaglehole R. Preventing chronic diseases: how many lives can we save? Lancet. 2005 Oct 29-Nov 4;366(9496):1578-82. doi: 10.1016/S0140-6736(05)67341-2.

    PMID: 16257345BACKGROUND

  • Fuster V, Voute J. MDGs: chronic diseases are not on the agenda. Lancet. 2005 Oct 29-Nov 4;366(9496):1512-4. doi: 10.1016/S0140-6736(05)67610-6. No abstract available.

    PMID: 16257330BACKGROUND

  • Monteiro CA, Conde WL, Popkin BM. Is obesity replacing or adding to undernutrition? Evidence from different social classes in Brazil. Public Health Nutr. 2002 Feb;5(1A):105-12. doi: 10.1079/PHN2001281.

    PMID: 12027272BACKGROUND

  • Yang D, Fontaine KR, Wang C, Allison DB. Weight loss causes increased mortality: cons. Obes Rev. 2003 Feb;4(1):9-16. doi: 10.1046/j.1467-789x.2003.00092.x.

    PMID: 12608523BACKGROUND

  • Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983 May;67(5):968-77. doi: 10.1161/01.cir.67.5.968.

    PMID: 6219830BACKGROUND

  • Frankel PH. Obesity and cancer. N Engl J Med. 2003 Jul 31;349(5):502-4; author reply 502-4. No abstract available.

    PMID: 12892102BACKGROUND

  • Allison DB, Saunders SE. Obesity in North America. An overview. Med Clin North Am. 2000 Mar;84(2):305-32, v. doi: 10.1016/s0025-7125(05)70223-6.

    PMID: 10793644BACKGROUND

  • Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB. Annual deaths attributable to obesity in the United States. JAMA. 1999 Oct 27;282(16):1530-8. doi: 10.1001/jama.282.16.1530.

    PMID: 10546692BACKGROUND

  • Harris T, Cook EF, Garrison R, Higgins M, Kannel W, Goldman L. Body mass index and mortality among nonsmoking older persons. The Framingham Heart Study. JAMA. 1988 Mar 11;259(10):1520-4.

    PMID: 3339789BACKGROUND

  • Chu SY, Callaghan WM, Kim SY, Schmid CH, Lau J, England LJ, Dietz PM. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care. 2007 Aug;30(8):2070-6. doi: 10.2337/dc06-2559a. Epub 2007 Apr 6.

    PMID: 17416786BACKGROUND

  • Ohlin A, Rossner S. Maternal body weight development after pregnancy. Int J Obes. 1990 Feb;14(2):159-73.

    PMID: 2341224BACKGROUND

  • Greene GW, Smiciklas-Wright H, Scholl TO, Karp RJ. Postpartum weight change: how much of the weight gained in pregnancy will be lost after delivery? Obstet Gynecol. 1988 May;71(5):701-7.

    PMID: 3357658BACKGROUND

  • Linne Y, Barkeling B, Rossner S. Long-term weight development after pregnancy. Obes Rev. 2002 May;3(2):75-83. doi: 10.1046/j.1467-789x.2002.00061.x.

    PMID: 12120423BACKGROUND

  • Gore SA, Brown DM, West DS. The role of postpartum weight retention in obesity among women: a review of the evidence. Ann Behav Med. 2003 Oct;26(2):149-59. doi: 10.1207/S15324796ABM2602_07.

    PMID: 14534032BACKGROUND

  • Lederman SA. Pregnancy weight gain and postpartum loss: avoiding obesity while optimizing the growth and development of the fetus. J Am Med Womens Assoc (1972). 2001 Spring;56(2):53-8.

    PMID: 11326797BACKGROUND

  • Boardley DJ, Sargent RG, Coker AL, Hussey JR, Sharpe PA. The relationship between diet, activity, and other factors, and postpartum weight change by race. Obstet Gynecol. 1995 Nov;86(5):834-8. doi: 10.1016/0029-7844(95)00283-W.

    PMID: 7566859BACKGROUND

  • Parker JD, Abrams B. Differences in postpartum weight retention between black and white mothers. Obstet Gynecol. 1993 May;81(5 ( Pt 1)):768-74.

    PMID: 8469470BACKGROUND

  • Potter S, Hannum S, McFarlin B, Essex-Sorlie D, Campbell E, Trupin S. Does infant feeding method influence maternal postpartum weight loss? J Am Diet Assoc. 1991 Apr;91(4):441-6.

    PMID: 2016492BACKGROUND

  • Scholl TO, Hediger ML, Schall JI, Ances IG, Smith WK. Gestational weight gain, pregnancy outcome, and postpartum weight retention. Obstet Gynecol. 1995 Sep;86(3):423-7. doi: 10.1016/0029-7844(95)00190-3.

    PMID: 7651655BACKGROUND

  • Bradley PJ. Conditions recalled to have been associated with weight gain in adulthood. Appetite. 1985 Sep;6(3):235-41.

    PMID: 4073883BACKGROUND

  • Hill JO, Peters JC. Environmental contributions to the obesity epidemic. Science. 1998 May 29;280(5368):1371-4. doi: 10.1126/science.280.5368.1371.

    PMID: 9603719BACKGROUND

  • Maddi SR, Khoshaba DM, Persico M, Bleecker F, VanArsdall G. Psychosocial correlates of psychopathology in a national sample of the morbidly obese. Obes Surg. 1997 Oct;7(5):397-404. doi: 10.1381/096089297765555377.

    PMID: 9730493BACKGROUND

  • Lundberg U, Frankenhaeuser M. Pituitary-adrenal and sympathetic-adrenal correlates of distress and effort. J Psychosom Res. 1980;24(3-4):125-30. doi: 10.1016/0022-3999(80)90033-1. No abstract available.

    PMID: 7441580BACKGROUND

  • Pop-Jordanova N. Psychological characteristics and biofeedback mitigation in preadolescents with eating disorders. Pediatr Int. 2000 Feb;42(1):76-81. doi: 10.1046/j.1442-200x.2000.01176.x.

    PMID: 10703241BACKGROUND

  • Coggon D, Martyn C, Palmer KT, Evanoff B. Assessing case definitions in the absence of a diagnostic gold standard. Int J Epidemiol. 2005 Aug;34(4):949-52. doi: 10.1093/ije/dyi012.

    PMID: 16076861BACKGROUND

  • Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.

    PMID: 8731275BACKGROUND

  • Kessler RC, Molnar BE, Feurer ID, Appelbaum M. Patterns and mental health predictors of domestic violence in the United States: results from the National Comorbidity Survey. Int J Law Psychiatry. 2001 Jul-Oct;24(4-5):487-508. doi: 10.1016/s0160-2527(01)00080-2. No abstract available.

    PMID: 11521422BACKGROUND

  • Kendler KS, Neale MC, Kessler RC, Heath AC, Eaves LJ. Major depression and generalized anxiety disorder. Same genes, (partly) different environments? Arch Gen Psychiatry. 1992 Sep;49(9):716-22. doi: 10.1001/archpsyc.1992.01820090044008.

    PMID: 1514877BACKGROUND

  • Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.

    PMID: 9435761BACKGROUND

  • Wittchen HU, Stein MB, Kessler RC. Social fears and social phobia in a community sample of adolescents and young adults: prevalence, risk factors and co-morbidity. Psychol Med. 1999 Mar;29(2):309-23. doi: 10.1017/s0033291798008174.

    PMID: 10218923BACKGROUND

  • McCarter-Spaulding DE. Medications in pregnancy and lactation. MCN Am J Matern Child Nurs. 2005 Jan-Feb;30(1):10-7; quiz 18-9.

    PMID: 15622140BACKGROUND

  • Fisher P, Ward A. Complementary medicine in Europe. BMJ. 1994 Jul 9;309(6947):107-11. doi: 10.1136/bmj.309.6947.107.

    PMID: 8038643BACKGROUND

  • Endler PC, Pongratz W, Smith CW, Schulte J. Non-molecular information transfer from thyroxine to frogs with regard to homeopathic toxicology. Vet Hum Toxicol. 1995 Jun;37(3):259-60. No abstract available.

    PMID: 7571362BACKGROUND

  • Dugoua JJ, Mills E, Perri D, Koren G. Safety and efficacy of St. John's wort (hypericum) during pregnancy and lactation. Can J Clin Pharmacol. 2006 Fall;13(3):e268-76. Epub 2006 Nov 3.

    PMID: 17085775BACKGROUND

  • McKenna L, McIntyre M. What over-the-counter preparations are pregnant women taking? A literature review. J Adv Nurs. 2006 Dec;56(6):636-45. doi: 10.1111/j.1365-2648.2006.04037.x.

    PMID: 17118042BACKGROUND

  • Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.

    PMID: 18780582BACKGROUND

  • Dayan J, Yoshida K. [Psychological and pharmacological treatments of mood and anxiety disorders during pregnancy and postpartum. Review and synthesis]. J Gynecol Obstet Biol Reprod (Paris). 2007 Oct;36(6):530-48. doi: 10.1016/j.jgyn.2007.06.004. Epub 2007 Jul 5. French.

    PMID: 17616265BACKGROUND

  • Charlton RA, Cunnington MC, de Vries CS, Weil JG. Data resources for investigating drug exposure during pregnancy and associated outcomes: the General Practice Research Database (GPRD) as an alternative to pregnancy registries. Drug Saf. 2008;31(1):39-51. doi: 10.2165/00002018-200831010-00004.

    PMID: 18095745BACKGROUND

  • Kyle PM. Drugs and the fetus. Curr Opin Obstet Gynecol. 2006 Apr;18(2):93-9. doi: 10.1097/01.gco.0000192974.61729.4c.

    PMID: 16601467BACKGROUND

  • Guelinckx I, Devlieger R, Beckers K, Vansant G. Maternal obesity: pregnancy complications, gestational weight gain and nutrition. Obes Rev. 2008 Mar;9(2):140-50. doi: 10.1111/j.1467-789X.2007.00464.x. Epub 2008 Jan 21.

    PMID: 18221480BACKGROUND

  • Polley BA, Wing RR, Sims CJ. Randomized controlled trial to prevent excessive weight gain in pregnant women. Int J Obes Relat Metab Disord. 2002 Nov;26(11):1494-502. doi: 10.1038/sj.ijo.0802130.

    PMID: 12439652BACKGROUND

  • Pearlstein T. Perinatal depression: treatment options and dilemmas. J Psychiatry Neurosci. 2008 Jul;33(4):302-18.

    PMID: 18592032BACKGROUND

  • Bonari L, Pinto N, Ahn E, Einarson A, Steiner M, Koren G. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry. 2004 Nov;49(11):726-35. doi: 10.1177/070674370404901103.

    PMID: 15633850BACKGROUND

  • Epstein LH, Wing RR, Penner BC, Kress MJ. Effect of diet and controlled exercise on weight loss in obese children. J Pediatr. 1985 Sep;107(3):358-61. doi: 10.1016/s0022-3476(85)80506-0.

    PMID: 4032130BACKGROUND

  • Harding TW, de Arango MV, Baltazar J, Climent CE, Ibrahim HH, Ladrido-Ignacio L, Murthy RS, Wig NN. Mental disorders in primary health care: a study of their frequency and diagnosis in four developing countries. Psychol Med. 1980 May;10(2):231-41. doi: 10.1017/s0033291700043993.

    PMID: 7384326BACKGROUND

  • Mari JJ, Williams P. A comparison of the validity of two psychiatric screening questionnaires (GHQ-12 and SRQ-20) in Brazil, using Relative Operating Characteristic (ROC) analysis. Psychol Med. 1985 Aug;15(3):651-9. doi: 10.1017/s0033291700031500.

    PMID: 4048323BACKGROUND

  • Mari JJ, Williams P. A validity study of a psychiatric screening questionnaire (SRQ-20) in primary care in the city of Sao Paulo. Br J Psychiatry. 1986 Jan;148:23-6. doi: 10.1192/bjp.148.1.23.

    PMID: 3955316BACKGROUND

  • Milgrom LR. Vitalism, complexity and the concept of spin. Homeopathy. 2002 Jan;91(1):26-31. doi: 10.1054/homp.2001.0013.

    PMID: 12371447BACKGROUND

  • Milgrom LR. Patient-practitioner-remedy (PPR) entanglement. Part 3. Refining the quantum metaphor for homeopathy. Homeopathy. 2003 Jul;92(3):152-60. doi: 10.1016/s1475-4916(03)00038-9.

    PMID: 12884898BACKGROUND

  • Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses. 2003 Feb;60(2):276-83. doi: 10.1016/s0306-9877(02)00386-9.

    PMID: 12606247BACKGROUND

  • Weingartner O. What is the therapeutically active ingredient of homeopathic potencies? Homeopathy. 2003 Jul;92(3):145-51. doi: 10.1016/s1475-4916(03)00037-7.

    PMID: 12884897BACKGROUND

  • Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.

    PMID: 9310601BACKGROUND

  • Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 Aug 27-Sep 2;366(9487):726-32. doi: 10.1016/S0140-6736(05)67177-2.

    PMID: 16125589BACKGROUND

  • Oberbaum M, Singer SR, Frass M. Homeopathic research after the Lancet meta analysis--a moment for introspection. Complement Ther Med. 2005 Dec;13(4):303-5. doi: 10.1016/j.ctim.2005.10.006. Epub 2005 Nov 17. No abstract available.

    PMID: 16338202BACKGROUND

  • Mathie RT. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy. 2003 Apr;92(2):84-91. doi: 10.1016/s1475-4916(03)00006-7.

    PMID: 12725250BACKGROUND

  • Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.

    PMID: 12614092BACKGROUND

  • White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax. 2003 Apr;58(4):317-21. doi: 10.1136/thorax.58.4.317.

    PMID: 12668794BACKGROUND

  • Jacobs J, Springer DA, Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J. 2001 Feb;20(2):177-83. doi: 10.1097/00006454-200102000-00012.

    PMID: 11224838BACKGROUND

  • Frei H, Thurneysen A. Homeopathy in acute otitis media in children: treatment effect or spontaneous resolution? Br Homeopath J. 2001 Oct;90(4):180-2. doi: 10.1054/homp.1999.0505.

    PMID: 11680801BACKGROUND

  • Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison TC. Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. BMJ. 2000 Aug 19-26;321(7259):471-6. doi: 10.1136/bmj.321.7259.471.

    PMID: 10948025BACKGROUND

  • Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatr Infect Dis J. 2003 Mar;22(3):229-34. doi: 10.1097/01.inf.0000055096.25724.48.

    PMID: 12634583BACKGROUND

  • Frass M, Linkesch M, Banyai S, Resch G, Dielacher C, Lobl T, Endler C, Haidvogl M, Muchitsch I, Schuster E. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy. 2005 Apr;94(2):75-80. doi: 10.1016/j.homp.2005.01.002.

    PMID: 15892486BACKGROUND

  • Olson CM. Achieving a healthy weight gain during pregnancy. Annu Rev Nutr. 2008;28:411-23. doi: 10.1146/annurev.nutr.28.061807.155322.

    PMID: 18422452BACKGROUND

  • Kiel DW, Dodson EA, Artal R, Boehmer TK, Leet TL. Gestational weight gain and pregnancy outcomes in obese women: how much is enough? Obstet Gynecol. 2007 Oct;110(4):752-8. doi: 10.1097/01.AOG.0000278819.17190.87.

    PMID: 17906005BACKGROUND

  • Idler EL, Benyamini Y. Self-rated health and mortality: a review of twenty-seven community studies. J Health Soc Behav. 1997 Mar;38(1):21-37.

    PMID: 9097506BACKGROUND

Related Links

MeSH Terms

Conditions

OverweightMental DisordersObesity

Interventions

Selenoprotein PPhosphorus, DietarySulfurPhosphorusHomeopathy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SelenoproteinsProteinsAmino Acids, Peptides, and ProteinsPhosphorus CompoundsInorganic ChemicalsChalcogensElementsComplementary TherapiesTherapeutics

Study Officials

  • Edgard C Vilhena, MD

    Medicine School - University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, student PhD

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 20, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 13, 2013

Record last verified: 2013-05

Locations

BR(1)